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To analyze the efficacy of using honey to treat acute cough in children. Systematic review, synthesis without meta-analysis. We searched PubMed, Scopus, CENTRAL, CINAHL, and Web of Science databases on August 15, 2022, for words honey and cough. Randomized controlled trials conducted in children were included. Risk-of-bias and evidence quality were assessed. Studies were not pooled due to lack of key information. Instead, we provided the range of observed effects for the main outcomes. Three hundred ninety-six papers were screened, and 10 studies were included. Two studies had high risk-of-bias and six had some concerns. Honey seemed to decrease cough frequency more than placebo/no treatment (range of observed effect 0.0–1.1 points) and cough medication (0.2–0.9 points). Sleep improved more often in the honey group (range of effect was 0.0–1.1) compared to placebo/no treatment and (− 0.2–1.1 points) compared to cough medication. Quality of the evidence was low to very low. Conclusion: We found low quality evidence that honey may be more effective than cough medication or placebo/no treatment in relieving symptoms and improving sleep in children with acute cough. Better quality randomized, placebo-controlled blinded trials are needed to confirm the effectiveness of honey in treating acute cough in children. Trial registration: CRD42022369577. What is Known: • Honey has been suggested to be effective as a symptomatic treatment in acute cough. • Prior randomized trials have had conflicting results and thus an overview of the literature was warranted. What is New: • Based on low quality evidence honey may be more effective than placebo or over-the-counter medications for acute symptom reliwef in cough. • Future studies with better reporting are needed to confirm the results. [ABSTRACT FROM AUTHOR]

The aim was to reflect on the unexpected finding of persistent pulmonary hypertension of the neonate (PPHN) and pulmonary hypertension in infants born within the Dutch STRIDER trial, its definition and possible pathophysiological mechanisms. The trial randomly assigned pregnant women with severe early-onset fetal growth restriction to sildenafil 25 mg three times a day versus placebo. Sildenafil use did not reduce perinatal mortality and morbidity, but did result in a higher rate of neonatal pulmonary hypertension (PH). The current paper reflects on the used definition, prevalence, and possible pathophysiology of the data on pulmonary hypertension. Twenty infants were diagnosed with pulmonary hypertension (12% of 163 live born infants). Of these, 16 infants had PPHN shortly after birth, and four had pulmonary hypertension associated with sepsis or bronchopulmonary dysplasia. Four infants with PPHN in the early neonatal period subsequently developed pulmonary hypertension associated with bronchopulmonary dysplasia in later life. Infants with pulmonary hypertension were at lower gestational age at delivery, had a lower birth weight and a higher rate of neonatal co-morbidity. The infants in the sildenafil group showed a significant increase in pulmonary hypertension compared to the placebo group (relative risk 3.67; 95% confidence interval 1.28 to 10.51, P = 0.02).Conclusion: Pulmonary hypertension occurred more frequent among infants of mothers allocated to antenatal sildenafil compared with placebo. A possible pathophysiological mechanism could be a "rebound" vasoconstriction after cessation of sildenafil. Additional studies and data are necessary to understand the mechanism of action.What Is Known: • In the Dutch STRIDER trial, persistent pulmonary hypertension in the neonate (PPHN) was more frequent among infants after antenatal sildenafil exposure versus placebo.What Is New: • The current analysis focuses on the distinction between PPHN and pulmonary hypertension associated with sepsis or bronchopulmonary dysplasia and on timing of diagnosis and aims to identify the infants at risk for developing pulmonary hypertension. • The diagnosis pulmonary hypertension is complex, especially in infants born after severe early-onset fetal growth restriction. The research field could benefit from an unambiguous consensus definition and standardized screening in infants at risk is proposed. [ABSTRACT FROM AUTHOR]

Oral sucrose is included in almost all recommendations for treatment of pain in newborns, but evidence if multiple doses might be more effective than a single standard dose is lacking. We designed a single-centre, double-blind, randomised, controlled trial. We enrolled preterm infants needing the heel prick procedure. Each enrolled infant was randomised to receive a single standard dose of sucrose 2 min before or a double dose of sucrose 2 min before, and 30 s after heel prick. Primary outcome was the efficacy of the two interventions tested by the premature infant pain profile-PIPP scale obtained at 30 s, 60 s, and 120 s after heel prick. Secondary outcome was the evaluation of the concordance between the PIPP scale and other pain scores more feasible in clinical practice. Seventy-two infants were randomised. No difference in pain perception as measured by the PIPP scale was found between the groups: median PIPP values 4.0(IQR 3.0-4.0) vs 3.0(IQR 3.0-4.0) at baseline; 6.0(IQR 5.0-10.0) vs 6.0(IQR 4.0-8.5) at 30 s; 6.0(IQR 4.0-7.0) vs 5.0(IQR 4.0-8.5) at 60 s and 5.0(IQR 4.0-7.0) vs 5.0(IQR 4.0-7.5) at 2 min, in the experimental and standard treatment groups, respectively (p = 0.9020). There was no correlation between PIPP scores and other pain scales.Conclusion: We do not recommend doubling the dose during heel prick.What is Known:• Oral sucrose is included in almost all international position papers and recommendations for the treatment of mild to moderate pain in newborns, associated with non-nutritive sucking and facilitated tucking• Premature infant pain profile (PIPP) scale is the gold standard for evaluation of pain in preterms but it is difficult to use in clinical practiceWhat is New:• Repeating a dose of 24% sucrose is not effective in reducing pain during the recovery phase of a skin breaking procedure• Other pain scales, easier to use in clinical practice, are not comparable with PIPP for the evaluation of procedural pain in preterms. [ABSTRACT FROM AUTHOR]

Introduction: In this paper, we evaluated the feasibility of a telemedical (TM) support program and its effect on glycemic control in adolescents with type 1 diabetes mellitus (T1DM). Thirty-six adolescents (m=20, median age at the start of the study: 15.3 years (range: 10.7-19.3 years), median age at diagnosis: 9.3 years (2.1-13.8 years), median duration of disease: 6.4 years (1.0-12.8 years), HbA1c>8%, all on intensified insulin therapy) were randomized in a crossover trial over 6 months (3 months with TM, 3 months with conventional support and paper diary (PD)). During the TM phase, the patients sent their data (date, time, blood glucose, carbohydrate intake, insulin dosage) via mobile phone, at least daily, to our server and diabetologists sent back their advice via short message service (SMS) once a week.Results: Glycemic control improved during the TM phase, while it deteriorated during the PD phase: TM-PD group HbA1c (%, median (range)): 9.05 (8-11.3) (at 0 months), 8.9 (6.9-11.3) (at 3 months), and 9.2 (7.4-12.6) (at 6 months), and PD-TM group: 8.9 (8.3-11.6), 9.9 (8.1-11), and 8.85 (7.3-11.7) (p<0.05). Patients rated the TM support program to be a good idea. Technical problems with General Packet Radio Service (GPRS) data transmission led to data loss and decreased patient satisfaction.Conclusion: Our telemedical support program, VIE-DIAB, proved to be feasible in adolescents and helped to improve glycemic control. [ABSTRACT FROM AUTHOR]

Results of community-based childhood obesity intervention programs do not provide strong evidence for their effectiveness. In this study, we evaluated the effect of the Thao-Child Health Program (TCHP), a community-based, multisetting, multistrategy intervention program for healthy weight development and lifestyle choices. In four Catalan cities, a total of 2250 children aged 8 to 10 years were recruited. Two cities were randomly selected for the TCHP intervention, and two cities followed usual health care policy. Children were selected from 41 elementary schools. Weight, height, and waist circumference were measured at baseline and after a mean follow-up of 15 months. Physical activity and adherence to the Mediterranean diet were measured with validated questionnaires. Generalized estimating equations (GEE) models were fitted to determine the intervention's effect on body mass index (BMI) z-score, waist-to-height ratio, Mediterranean diet adherence, and physical activity. Fully adjusted models revealed that the intervention had no significant effect on the BMI z-score, incidence of general and abdominal obesity, Mediterranean diet adherence, and physical activity. Waist-to-height ratio was significantly lower in controls than in the intervention group at follow-up (p < 0.004).Conclusions: The TCHP did not improve weight development, diet quality, and physical activity in the short term. What is Known: • There is inconsistent evidence for the efficacy of school-based childhood obesity prevention programs. • There is little evidence on the efficacy of childhood obesity intervention programs in other settings. What is New: • This paper contributes information about the efficacy of a multisetting and multistrategy Community Based Intervention (CBI) program that uses the municipality as its unit of randomization. • This CBI had no effect on the prevention and treatment of childhood obesity in the short term. [ABSTRACT FROM AUTHOR]

The objective of the paper is to assess the cost-effectiveness of targeted respiratory syncytial virus (RSV) prophylaxis based on a validated prediction rule with 1-year time horizon in moderately preterm infants compared to no prophylaxis. Data on health care consumption were derived from a randomised clinical trial on wheeze reduction following RSV prophylaxis and a large birth cohort study on risk prediction of RSV hospitalisation. We calculated the incremental cost-effectiveness ratio (ICER) of targeted RSV prophylaxis vs. no prophylaxis per quality-adjusted life year (QALYs) using a societal perspective, including medical and parental costs and effects. Costs and health outcomes were modelled in a decision tree analysis with sensitivity analyses. Targeted RSV prophylaxis in infants with a first-year RSV hospitalisation risk of > 10% resulted in a QALY gain of 0.02 (0.931 vs. 0.929) per patient against additional cost of €472 compared to no prophylaxis (ICER €214,748/QALY). The ICER falls below a threshold of €80,000 per QALY when RSV prophylaxis cost would be lowered from €928 (baseline) to €406 per unit. At a unit cost of €97, RSV prophylaxis would be cost saving.Conclusions: Targeted RSV prophylaxis is not cost-effective in reducing RSV burden of disease in moderately preterm infants, but it can become cost-effective if lower priced biosimilar palivizumab or a vaccine would be available. [ABSTRACT FROM AUTHOR]

This is the first meta-analysis of the available literature about the efficacy of metformin exclusively in pediatric patients with non-alcoholic fatty liver disease (NAFLD). We conducted a systematic literature search through major electronic databases till March 12, 2023, investigating the efficacy and safety of metformin in pediatric NAFLD. Weighted mean difference (WD) and standard deviation (SD) were used for continuous outcomes. In total, 4 randomized controlled trials (RCTs) with 309 pediatric patients with NAFLD were included in the meta-analysis. Metformin could not reach a statistically significant improvement in alanine aminotransferase (ALT) levels [(ALT: WMD = − 1.55 IU/L, 95% CI: − 5.38 to 2.28, I2 = 16%, p = 0.43), but had a statistically significant impact (p < 0.05) in insulin and HOMA-IR regulation, triglycerides, and high-density lipoprotein level improvement. Conclusion: According to the data of this meta-analysis, treatment with metformin failed to statistically improve liver enzymes but may be beneficial in the improvement of lipid parameters and insulin metabolism regulation in pediatric patients with NAFLD. As there are not enough available studies in the literature, the influence of metformin on liver ultrasonography or histology in pediatric NAFLD should be further analyzed in future studies. What is Known: • Lifestyle modification with weight loss through physical activity and dietary modification is the recommended treatment option for pediatric NAFLD. • Metformin may reduce steatosis on ultrasound and may have a beneficial role in liver histology collated with insulin resistance improvement. What is New: • Metformin may improve insulin sensitivity and lipid parameters in children with obesity and NAFLD. • Metformin does not have a significant effect on transaminase levels in children with obesity and NAFLD. [ABSTRACT FROM AUTHOR]

In pediatric oncology there are few examples of successful recruitment and retention strategies in psychosocial care research. This study aims to summarize experiences, challenges, and strategies for conducting randomized controlled trials (RCTs) of psychosocial intervention studies among children with cancer and their parent(s). We conducted a collective case study. To identify the cases, Pubmed and two trial registries were searched for ongoing and finished RCTs of psychosocial intervention studies for children with cancer and their parents. Online semi-structured expert interviews discussing recruitment and retention challenges and strategies were performed with principal investigators and research staff members of the identified cases. Nine studies were identified. Investigators and staff from seven studies participated, highlighting challenges and strategies within three major themes: eligibility, enrollment and retention. Regarding eligibility, collaborating constructively with healthcare professionals and involving them before the start of the study were essential. Being flexible, training the research staff, enabling alignment with the participants' situation, and providing consistency in contact between the research staff member and the families were important strategies for optimizing enrollment and retention. All studies followed a stepped process in recruitment. Conclusion: Although recruitment and retention in some selected studies were successful, there is a paucity of evidence on experienced recruitment and retention challenges in pediatric psychosocial research and best practices on optimizing them. The strategies outlined in this study can help researchers optimize their protocol and trial-implementation, and contribute to better psychosocial care for children with cancer and their parents. Trial Registration: This study is not a clinical trial. What is Known: • Performing RCTs is challenging, particularly in pediatric psychosocial research when both the child and parent are targeted. Recruitment and retention are common concerns. In pediatric oncology, there are few examples of successful recruitment and retention strategies in psychosocial care research. What is New: • Key strategies to collaborate constructively with healthcare professionals were outlined. Being flexible, training the research staff, alignment with the participant's situations and providing consistency in contact between the research staff member and the families were considered as essential strategies. [ABSTRACT FROM AUTHOR]

The physical and psychological benefits of physical activity are well established. However, there is no consensus regarding the effects of physical activity on children's academic performance in general and in specific subjects. We conducted this systematic review and meta-analysis to identify forms of physical activity that are suitable for improving the physical activity levels and academic performance of children aged 12 years and under. The PubMed, Web of Science, Embase, and Cochrane Library databases were searched. Included studies had to meet the following criteria: randomized controlled trials examining the effect of physical activity interventions on children's academic performance. Stata 15.1 software was used to conduct the meta-analysis. A total of 16 studies were included, and the results showed that the "physical activity + academic curriculum" format had a positive effect on children's academic performance. Physical activity had a stronger effect on math performance than on reading and spelling performance (SMD = 0.75, 95% CI: 0.30,1.19, P < 0.001). Conclusion: The impact of physical activity on children's academic performance varies based on the type of physical activity intervention, with "physical activity + academic curriculum" format having a better effect on academic performance. The effect of physical activity interventions on children's academic performance also varies by subject; the effect is strongest for math. Trial registration: Registration and protocol CRD42022363255. What is Known: • The physical and psychological benefits of physical activity are well established. • Previous meta-analyses have failed to demonstrate the impact of physical activity on the general and subject-specific academic performance of children aged 12 and under. What is New: • The PAAL form of physical activity has a better effect on the academic performance of children aged 12 and under. • The benefit of physical activity also varies by subject, with the greatest effect being observed for math. [ABSTRACT FROM AUTHOR]

Impaired muscle strength, proprioceptive and vestibular deficits, and orthopedic dysfunction are common disorders associated with Down syndrome (DS). Hippotherapy uses the horses' multidimensional movement to improve posture, balance, and overall function, both motor and sensory. Research evidence supports hippotherapy as an effective, medically recognized intervention for the rehabilitation of gross motor skills. The aim of this study was to determine the effect of hippotherapy on balance, functional mobility, and functional independence in children with DS. Thirty-four children with DS were randomly assigned to the experimental (hippotherapy) and control groups after the initial assessment. Both groups received physiotherapy including balance exercises, and the experimental group also received hippotherapy as an integrative therapy. Pediatric Balance Scale (PBS), Timed Up and Go Test (TUG), and Functional Independence Measure for Children (WeeFIM) were used before and after the intervention. Baseline outcome measures (PBS, TUG, WeeFIM) were statistically similar between groups (p > 0.05). After the intervention, PBS and TUG scores improved in both groups (p < 0.05). On the other hand, WeeFIM scores improved just in the hippotherapy group (p < 0.05). Conclusion: Therefore, providing hippotherapy as an integrative therapy to physiotherapy will be more effective in improving the functional independence of children with DS. Trial registration: NCT05297149 (March 2022, retrospectively registered). What is Known: • Hippotherapy has an improvement effect on balance and functional independence in different diseases and age groups, but the evidence is limited in DS. • There is limited evidence about the effect of hippotherapy on functional mobility in different diseases and age groups, but there is no evidence in DS. What is New: • Hippotherapy is a safe and effective approach to support improvement in functional independence in children with DS. [ABSTRACT FROM AUTHOR]

Although antimicrobials are the cornerstone of neonatal sepsis management, adjunctive therapies are required to improve outcomes. The aim of our study was to evaluate the effect of exchange transfusion (ET) on mortality (primary outcome) in neonatal sepsis, as well as on immunoglobulin, complement and neutrophil levels and assess its complications (secondary outcomes). Databases searched include PubMed, NCBI, Google Scholar, CINHAL, Ovid and Scopus. Randomized controlled trials (RCTs), controlled observational studies (COSs) and uncontrolled observational studies (UOSs) reporting mortality data from using ET in neonatal sepsis were included. Studies with additional interventions, non-septic ET indications and populations aged > 28 days were excluded. Data extracted include demographics, features of study, sepsis and ET, as well as mortality rates, immunological and laboratory changes and complications. Data was meta-analysed and displayed using forest plots. The meta-analysis of 14 studies (3 RCTs, 11 COSs) revealed a mortality benefit in septic neonates who underwent ET-RR 0.72 (CI 0.61–0.86, p = 0.01) and a significant increase in pooled immunological parameters (immunoglobulin, complement levels) (SMD 1.13, [0.25, 2.02], p = 0.02) and neutrophil levels (SMD 1.07 [0.04, 2.11], p = 0.03) compared to controls. The descriptive analysis of 9 UOSs revealed thrombocytopenia as the most frequently reported complication (n = 48). Moderate–high risk of bias was largely due to inadequate sample sizes and follow-up durations. Conclusion: Currently, the use of ET in neonatal sepsis is not directly recommended due to low certainty of evidence, inadequate power and moderate–high risk of bias and heterogeneity. Trial registration: PROSPERO (CRD42020176629) (https://www.crd.york.ac.uk/prospero/display%5frecord.php?RecordID=176629) What is Known: • Exchange transfusion is one of the adjunctive methods for treatment of neonatal sepsis. What is New: • The pooled analysis of all studies shows that exchange transfusion has a low certainty of evidence in the context of neonatal mortality. However, at this point, this intervention cannot be refuted or recommended due to heterogeneity of studies and inadequate power. [ABSTRACT FROM AUTHOR]

Late-preterm infants (LPT) are at increased risk for long-term neurodevelopmental sequelae and iron deficiency. The aim of the study is to assess the positive effect of iron supplementation on psychomotor development in healthy LPT. We designed a randomized placebo-controlled double-blind trial dividing the newborns into two groups. Every patient was assessed using the Griffiths Mental Development Scales (GMDS)-II edition at 12-month post-conceptional age. The study was performed at the Neonatology Unit of our Hospital, in Italy. Sixty-six healthy LPT infants born between 340⁄7 and 366⁄7 weeks of gestational age were enrolled in the study. One group received martial prophylaxis from the third week of life to 6 months of post-conceptional age (2 mg/kg/day of iron pidolate), the other received placebo. Fifty-two of the enrolled infants were assessed using the GMDS at 12-month of post-conceptional age. Statistical analysis of the mean scores of the Griffiths subscales was performed. There was a difference in the mean developmental quotient (DQ) (p < 0.01) between the two groups: iron group mean DQ 121.45 ± 10.53 vs placebo group mean DQ 113.25 ± 9.70. Moreover, mean scores of the Griffiths subscales A, B, and D showed significant differences between the two groups (scale A p < 0.05, scale B p < 0.02, scale D p < 0.01, respectively). Conclusions: We recommend that all LPT neonates receive iron supplementation during the first 6 months of life in order to improve their 1-year neurodevelopmental quotient. What is Known: • Late-preterm infants (LPT) are at increased risk for long-term neurodevelopmental sequelae and also for iron deficiency. • Iron deficiency is an independent risk factor for adverse neurological outcomes. What is New: • Healthy late-preterm who received iron supplementation during the first 6 months of life achieved better neurological outcomes at 12-month post-conceptional age than LPT who received placebo. • Our study strongly supports the need for the implementation of martial prophylaxis in LPT neonates. [ABSTRACT FROM AUTHOR]

Steroids are the cornerstone of the treatment of childhood nephrotic syndrome. The optimal duration for the first episode remains a matter of debate. The aim of this study is to determine whether the 8 weeks International Study of Kidney Disease in Children (ISKDC) regimen is equally effective as the 12 weeks steroid regimen from the German society of pediatric nephrology (Arbeitsgemeinschaft für Pädiatrische Nephrologie [APN]). An individual patient data (IPD) meta-analysis of randomized controlled trials reporting on prednisolone treatment for a first episode of childhood nephrotic syndrome was conducted. European trials aimed at investigating the ISKDC and/or APN steroid regimen were selected. The lead investigators of the selected trials were requested to provide the IPD of the specific treatment groups. Four trials included European cohorts using dosing schedules according to the regimens studied. IPD of two trials were available. A significant difference was found in time to first relapse after cessation of steroid treatment between the 8 and 12 weeks treatment group with a median time to relapse of 29 and 63 days, respectively. Moreover, relapse rate ratios during total follow-up were 51% higher for the 8 weeks regimen. Finally, younger children have a significantly lower time to first relapse and frequently relapsing nephrotic syndrome. Conclusions: The results of this IPD meta-analysis suggest that the 8 weeks steroid regimen for a first episode of steroid-sensitive nephrotic syndrome may not be equally effective as the 12 weeks steroid regimen. Moreover, this study highlights the importance of using uniform definitions to enable accurate comparison and interpretation of trial results. Trial registration: Registration number: CRD42020199244, date of registration 16-08-2020 What is Known: • Steroids are the cornerstone of the treatment of childhood nephrotic syndrome, however the optimal duration for the first episode remains a matter of debate. • Currently, the 8 weeks ISKDC protocol and 12 weeks APN protocol are among the most frequently used protocols in Europe. What is New: • The 8 weeks steroid regimen for a first episode of steroid-sensitive nephrotic syndrome may not be equally effective as the 12 weeks steroid regimen for the treatment of a first episode of nephrotic syndrome. • Younger children have a significantly shorter time to first relapse and time to frequent relapsing nephrotic syndrome. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess whether home phototherapy was feasible and safe in a cohort of otherwise healthy term-born neonates who fulfilled the criteria for in-hospital phototherapy. This was a randomized controlled trial in which term newborns with a total serum bilirubin of 18–24 mg/dL (300–400 μmol) were randomized to either home phototherapy or conventional in-hospital phototherapy. The primary outcome measurements were safety and efficacy, length of stay and the number of failed treatments. The secondary outcomes were the number of blood samples and weight gain during treatment. One hundred forty-seven patients were recruited, 69 patients randomized to conventional phototherapy and 78 to home phototherapy. The results showed that no patients needed blood exchange and only 4% of the patients allocated to home phototherapy were admitted to the hospital. The duration of phototherapy, length of stay, amount of blood tests and weight change showed no statically significant differences. Conclusion: Home phototherapy could be a safe alternative to inpatient phototherapy for otherwise healthy newborns with hyperbilirubinemia if daily checkups and 24/7 telephone support can be provided. The parents should be informed to contact the hospital immediately if they fail to perform the treatment at home. Trial registration: Clinicaltrials.gov NCT03536078 What is Known: • Phototherapy in the hospital is a safe and effective treatment without major side effects. • Fibre optic equipment has made the choice of home phototherapy possible. What is New: • This is the first randomized controlled trial comparing home phototherapy with hospital phototherapy. • Results indicate that home phototherapy could be considered as a safe and feasible alternative when performed according to instructions given, to hospital treatment for otherwise healthy term newborns. [ABSTRACT FROM AUTHOR]

The efficacy of antipyretics for preventing febrile seizure recurrence has been reported by a recent study, and the results might overturn previous evidence. We systematically reviewed the efficacy of antipyretics in the prevention of febrile seizure recurrence in children focused on the timing of its administration. We searched the Medline, Embase, and Cochrane Central Register of Controlled Trials databases for randomized and quasi-randomized trials and prospective non-randomized studies of aged up to 60 months, diagnosed with febrile seizure, who were treated with antipyretics. Data were extracted from eight studies. Only one study reported that antipyretics prevented the recurrence of febrile seizures within the same fever episode (9.1% in the acetaminophen group vs. 23.5% in the control group, p < 0.01). Four studies found no evidence for the efficacy of antipyretics in preventing febrile seizure recurrence in distant fever episodes (odds ratio, 0.92; 95% confidence interval, 0.57–1.48, for two randomized controlled studies). Conclusion: This review provides very limited support for the use of antipyretics in preventing febrile seizure recurrence within the same fever episode and no evidence for its use in distant fever episodes. New studies are required to evaluate this topic further and determine whether the effectiveness of antipyretics is based on intervention timing. What is Known: • Reviews of prophylactic drug management among febrile seizure children found that antipyretics had no significant benefits. • Recent data suggest that antipyretics are effective in preventing febrile seizures. What is New: • Weak evidence suggests a possible role in preventing febrile seizure recurrence within the same fever episode. • There is clearly no role for antipyretic prophylaxis in preventing febrile seizures during distant fever episodes. [ABSTRACT FROM AUTHOR]

Our aim was to assess the efficacy and safety of intravenous (i.v.) paracetamol vs. i.v. ibuprofen for the treatment of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. This is a multicenter randomized controlled study. Infants with a gestational age of 25+0–31+6 weeks were randomized to receive i.v. paracetamol (15 mg/kg/6 h for 3 days) or i.v. ibuprofen (10-5-5 mg/kg/day). The primary outcome was the closure rate of hsPDA after the first treatment course with paracetamol or ibuprofen. Secondary outcomes included the constriction rate of hsPDA, the re-opening rate, and the need for surgical closure. Fifty-two and 49 infants received paracetamol or ibuprofen, respectively. Paracetamol was less effective in closing hsPDA than ibuprofen (52 vs. 78%; P = 0.026), but the constriction rate of the ductus was similar (81 vs. 90%; P = 0.202), as confirmed by logistic regression analysis. The re-opening rate, the need for surgical closure, and the occurrence of adverse effects were also similar. Conclusions: Intravenous paracetamol was less effective in closing hsPDA than ibuprofen, but due to a similar constriction effect, its use was associated with the same hsPDA outcome. These results can support the use of i.v. paracetamol as a first-choice drug for the treatment of hsPDA. Trial registration:Clinicaltrials.gov: NCT02422966, Date of registration: 04/09/2015; EudraCT no: 2013-003883-30. What is Known: • The successful closure of patent ductus arteriosus with oral paracetamol has been recently reported in several preterm infants, but only one randomized controlled study investigated the efficacy of intravenous paracetamol. What is New: • Intravenous paracetamol is less effective in closing hsPDA than ibuprofen, but have a similar constriction effect. • These results can support the use of i.v. paracetamol as a first-choice drug for the treatment of hsPDA. [ABSTRACT FROM AUTHOR]

This study sought to determine whether adding virtual reality (VR) was superior to standard of care alone in facilitating reduction in pain and anxiety among children who underwent intravenous catheterization in the emergency department (ED). Sixty-six children aged 6–16 years who needed intravenous placement received VR, or standard of care in the ED (videos, television, iPad, child life specialist). Outcome measures included change in pain score, level of anxiety, patient and parent satisfaction (pain and anxiety), number of trials, and procedure time. Compared with controls, the intervention group had similar age, sex, number of trials, and anesthetic use. Time of procedure was shorter in the VR group (median 5 min) but this was not statistically significant compared with 7 min for the control group. Pain in the intervention group was lower, even before the procedure. Difference in pain (before and after) and anxiety (after the procedure) were similar in both groups. Satisfaction from anxiety management was higher for the VR group (p < 0.007) and children rated VR significantly more "fun" (p < 0.024). Conclusion: VR was an effective distraction tool and increased satisfaction from anxiety management for this common pediatric procedure, and should be incorporated in management of anxiety in children in the ED setting. Trial registration: clinicaltrials.gov ID NCT03681730, https://clinicaltrials.gov/ct2/show/NCT03681730 What is Known: • Virtual reality is an evolving computer technology that shows some promise in the areas of acute and chronic pain management due to its ability to create effective distraction. What is New: • We report that among children in the emergency setting with intravenous catheterization, satisfaction from the use of VR for anxiety management should support implementation of VR systems for this procedure [ABSTRACT FROM AUTHOR]

Aromatherapy with essential oils can be used to relieve children. The aim of this study was to evaluate the correlations between psychological and physiologic findings after lavender oil inhalation among children assigned to undergo tooth extraction. A total of 126 children aged between 6 and 12 years were enrolled in the study. The groups were randomly divided into control and lavender groups. The lavender group inhaled 100% lavender oil for 3 min before the interventions, the control group received no prior application. Psychological assessments were made using face image scale (FIS), Face, Legs, Activity, Cry, Consolability (FLACC) and Wong-Baker pain rating scale (WBS). Physiologic changes were assessed using vital signs evaluations. All parameters were noted prior to applications, after inhalation, anesthesia injection, and tooth extraction. The lavender group showed significant lower anxiety and pain scores after tooth extraction (p < 0.05). Significantly lower levels of blood pressures and a significant pulse rate drop were found after inhalation in the lavender group. A statistically significant increase in heart rate was observed after anesthesia injection and tooth extraction in the control group (p < 0.05).Conclusion: Lavender oil can be preferred as a treatment of choice in routine pediatric dentistry.Trial registration number: NCT04115891 (Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children)What is Known:• Dental anxiety is the most common factor that causes children to have difficulty with the dentist and their parents during treatment.• Aromatherapy with essential oils can be used to relieve children.What is New:• Aromatherapy with lavender oil relieves the child by reducing the level of anxiety and facilitates dental treatment.• During surgical procedures such as local anesthesia and tooth extraction, lavender oil inhalation decreases pain levels of children. [ABSTRACT FROM AUTHOR]

Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults and children aged ≥ 6 years. Pharmacokinetic data for children aged 6-11 years were extracted post hoc from a study in which children (2-11 years) with allergic rhinoconjunctivitis or urticaria received oral bilastine (10 mg/day). Maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC) data were compared with adult pharmacokinetic data from seven clinical studies (bilastine 20 mg/day). Safety data for children aged 6-11 years were extracted post hoc from a phase III randomized controlled trial of children (2-11 years) with allergic rhinoconjunctivitis or chronic urticaria receiving once-daily bilastine 10 mg or placebo for 12 weeks. Exposure and Cmax values were similar for children (6-11 years) and adults: median pediatric/adult ratios for AUC0-24 and Cmax were 0.93 and 0.91, respectively. There was no significant difference in the incidence of treatment-emergent adverse in children (6-11 years) receiving bilastine 10 mg or placebo.Conclusion: Pharmacokinetic and safety analyses in children aged 6-11 years support the suitability of the pediatric dose of bilastine 10 mg and confirm that the safety profiles of bilastine and placebo are similar.What is Known:• Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults (20 mg/day) and children aged ≥ 6 years (10 mg/day).• An ontogenic model based on adult data and pharmacokinetic/pharmacodynamic simulations supported the selection of a bilastine dose of 10 mg/day in children aged 2-11 years. Bilastine 10 mg/day was shown to have a safety profile similar to that of placebo in a large phase III randomized clinical trial in children aged 2-11 years.What is New:• As bilastine is approved in Europe for children aged ≥6 years, the current study reports the results of two post hoc analyses of pharmacokinetic and safety data in children aged 6-11 years.• Analysis of pharmacokinetic and safety data in children aged 6-11 years supports the suitability of the pediatric dose of bilastine 10 mg and confirms that its safety profile is similar to that of placebo. [ABSTRACT FROM AUTHOR]

Cow's milk protein allergy (CMPA) is the commonest food allergy in infancy and is associated with significant health burden. Given their immune modulatory properties, probiotics have been proposed as a strategy for management of CMPA. We aimed to systematically review efficacy and safety of probiotics in the management of CMPA. Databases PubMed, EMBASE, CINAHL, Cochrane Central Library, and Google scholar were searched in August 2018 for randomized controlled trials (RCT) of probiotic supplementation as an adjunct in the management of infants with suspected/proven CMPA. Primary outcomes were resolution of hematochezia and acquisition of tolerance to CMP at 6, 12, 24, and 36 months. Secondary outcomes included effect on allergic symptoms (SCORAD index), growth, gut microbiota, and adverse effects. A total of 10 RCTs (n = 845; probiotics, 422; control, 423) with low to unclear risk of bias were included. Meta-analysis showed probiotic supplementation was not associated with earlier resolution of hematochezia (n = 87; RR: 1.45 (95% CI: 0.96-2.18), p = 0.08; level of evidence (LOE), very low), in presumed CMPA. In confirmed CMPA, probiotics were associated with higher rate of acquisition of tolerance to CMP at the end of 3 years compared with placebo (N = 493; RR, 1.47; 95% CI, (1.17-1.84); p = 0.0009; LOE, low]. Meta-analysis was not possible for other outcomes. There were no probiotic related adverse effects. Conclusion: Limited low-quality evidence indicates that probiotic supplementation may be associated with earlier acquisition of tolerance to CMP in children with CMPA. Large well-designed trials are essential to confirm these findings. What is Known: • Cow's milk protein allergy (CMPA) is one of the commonest food allergies in children. CMPA is associated with significant socioeconomic burden. • Elimination diet and extensively hydrolyzed formula is the mainstay of the management of CMPA. What is New: • This first systematic review of randomized controlled trials shows that probiotics as an adjuvant can lead to earlier acquisition of tolerance to CMP in children at 36 months of age. However, the evidence is low quality and influenced by data from one large study. • Probiotic supplementation was not associated with earlier resolution of hematochezia. [ABSTRACT FROM AUTHOR]

We compared epinephrine and dopamine as a first-line vasoactive drug in 40 neonates (enrolled in two gestational age strata ≤ 306/7 and ≥ 310/7 weeks) with fluid-refractory septic shock. Epinephrine or dopamine was initiated at 0.2 or 10 μg/kg/min, respectively. If shock persisted after 15 min, epinephrine or dopamine was increased to 0.3 or 15 μg/kg/min, respectively (16-30 min), and thereafter to 0.4 or 20 μg/kg/min (31-45 min). Proportion of neonates achieving 'reversal of shock' (defined as systolic and diastolic BP > fifth centile and capillary filling time < 3 s and left ventricular output ≥ 150 mL/kg/min) by 45 min [5 (25%) vs 6 (30%), RR 0.83 (95% CI 0.30, 2.29)]; haemodynamic stability (shock reversal for ≥ 120 min without escalation of vasoactive drugs) anytime during therapy [10 (50%) vs 6 (30%), RR 1.67 (95% CI 0.75, 3.71)]; and all-cause mortality by 28 days [14 (70%) vs 16 (80%), RR 0.87 (95% CI 0.61, 1.26)] were comparable in the epinephrine and dopamine groups, respectively. On stratified analysis, we observed an interaction of gestational age strata with the group of allocation favouring epinephrine in neonates ≤ 306/7 weeks.Conclusion: Epinephrine (0.2-0.4 μg/kg/min) and dopamine (10-20 μg/kg/min) had comparable efficacy and safety in neonatal septic shock.Clinical Trial registry name and registration number: The study was registered with Clinical Trial Registry of India CTRI/2015/10/006285. What is Known: • The choice of vasoactive drugs in neonatal septic shock is empirical and dopamine is the conventional first-line vasoactive drug. • There are no randomized controlled trials comparing dopamine and epinephrine in neonatal septic shock. What is New: • In this study, epinephrine and dopamine had comparable efficacy and safety as a first-line vasoactive drug in management of neonatal septic shock. • On stratified analysis in a limited sample, epinephrine was associated with better outcomes in neonates ≤ 306/7 weeks. [ABSTRACT FROM AUTHOR]

Severe complications due to Shigatoxin-associated hemolytic uremic syndrome (STEC-HUS) currently present a serious challenge since no specific treatment for this condition is available. Eculizumab, a terminal complement inhibitor, has been used especially in STEC-HUS patients with severe neurological involvement, but the efficacy remains undetermined. In order to determine its efficacy, we searched the databases Pubmed, Web of Science, Embase, and LiLACS for reports describing outcomes of eculizumab administration in STEC-HUS. We retrieved 11 reports ranging from case reports to cohort studies with the largest study population emanating from the 2011 German outbreak. Outcomes were variable and difficult to interpret in light of the absence of high-quality studies but seemed to point towards potential efficacy of eculizumab if administered early in the course.Conclusion: The efficacy of eculizumab in STEC-HUS could not be established nor disproven based on current data, and there is a desperate need for randomized controlled trials. What is known? • Eculizumab has been used in complicated cases of Shigatoxin-associated hemolytic uremic syndrome but the efficacy remains unknown? What is new? • Eculizumab might be efficacious if given early in selected cases of Shigatoxin-associated hemolytic uremic syndrome; however, randomized trials are needed to assess this. [ABSTRACT FROM AUTHOR]

Upper Respiratory Tract Infections (URTI) are very common in children having no effective pharmacological treatment. This study aimed to compare the effect of caregivers' health education regarding children's respiratory infections and the effect of a rhinopharyngeal clearance protocol in children with URTI. A factorial trial was conducted in 138 children up to 3 years, attending day-care centres. Children were distributed into four groups: control group (CG) (n = 38); education group (EG) (n = 34); intervention group (IG) (n = 35); and education and intervention group (E + IG) (n = 31). A Diary of Records was kept by caregivers during 1 month. There were significant differences between groups concerning: Lower Respiratory Tract Infections (CG = 29.4%; EG = 10.7%; IG = 3.8%; E + IG = 0.0%; p = 0.014); acute otitis media (CG = 32.4%; EG = 7.1%; IG = 11.5%; E + IG = 7.7%; p = 0.014); medical consultations (CG = 70.6%; EG = 42.9%; IG = 38.5%; E + IG = 30.8%; p = 0.021); antibiotics (CG = 44.1%; EG = 7.1%; IG = 23.1%; E + IG = 15.4%; p = 0.006); days missed from day-care (CG = 55 days; EG = 22 days; IG = 14 days; E + IG = 6 days; p = 0.020); days missed from employment (CG = 31 days; EG = 20 days; IG = 5 days; E + IG = 1 day; p = 0.021); and nasal clearance techniques (CG = 41.4%; EG = 78.6%; IG = 57.7%; E + IG = 84.6%; p = 0.011).Conclusion: This study showed that the most positive impact on children's health outcomes occurred when combining health education of caregivers, regarding children's respiratory infections, with a rhinopharyngeal clearance protocol in children with URTI. What is Known: • Upper Respiratory Tract Infections are very common in children but still do not have an effective pharmacological treatment. • This generates a great burden of disease for the child and families, increasing the use of antibiotics. What is New: • This study is the first one that aims to analyze the effects of caregivers' health education in comparison to non-pharmacological intervention in acute respiratory infections in children. • It shows a positive impact on children's health outcomes, empowering caregivers regarding their child's health and reducing the burden of disease, medical consultations and the use of antibiotics. [ABSTRACT FROM AUTHOR]

Acute gastroenteritis (AGE) is one of the most frequent reasons for young children to visit emergency departments (EDs). We aimed to evaluate (1) feasibility of a nurse-guided clinical decision support system for rehydration treatment in children with AGE and (2) the impact on diagnostics, treatment, and costs compared with usual care by attending physician. A randomized controlled trial was performed in 222 children, aged 1 month to 5 years at the ED of the Erasmus MC-Sophia Children's hospital in The Netherlands ( 2010-2012). Outcome included (1) feasibility, measured by compliance of the nurses, and (2) length of stay (LOS) at the ED, the number of diagnostic tests, treatment, follow-up, and costs. Due to failure of post-ED weight measurement, we could not evaluate weight difference as measure for dehydration. Patient characteristics were comparable between the intervention (N = 113) and the usual care group (N = 109). Implementation of the clinical decision support system proved a high compliance rate. The standardized use of oral ORS (oral rehydration solution) significantly increased from 52 to 65%(RR2.2, 95%CI 1.09-4.31 p < 0.05). We observed no differences in other outcome measures.Conclusion: Implementation of nurse-guided clinical decision support system on rehydration treatment in children with AGE showed high compliance and increase standardized use of ORS, without differences in other outcome measures. What is Known: • Acute gastroenteritis is one of the most frequently encountered problems in pediatric emergency departments. • Guidelines advocate standardized oral treatment in children with mild to moderate dehydration, but appear to be applied infrequently in clinical practice. What is New: • Implementation of a nurse-guided clinical decision support system on treatment of AGE in young children showed good feasibility, resulting in a more standardized ORS use in children with mild to moderate dehydration, compared to usual care. • Given the challenges to perform research in emergency care setting, the ED should be experienced and adequately equipped, especially during peak times. [ABSTRACT FROM AUTHOR]

Unlabelled: Probiotics may benefit in cystic fibrosis (CF) as gut dysbiosis is associated with gastrointestinal symptoms and exacerbation of respiratory symptoms in CF. We conducted a systematic review of randomized controlled trials (RCTs) and non-RCTs of probiotic supplementation in children with CF, using the Cochrane methodology, preferred reporting items for systematic reviews (PRISMA) statement, and meta-analysis of observational studies in epidemiology (MOOSE) guidelines. Primary outcomes were pulmonary exacerbations, duration of hospitalization and antibiotics, and all-cause mortality. Secondary outcomes included gastrointestinal symptoms, markers of gut inflammation, and intestinal microbial balance. A total of nine studies (RCTs, 6, non-RCTs, 3; N = 275) with some methodological weaknesses were included in the review. The pooled estimate showed significant reduction in the rate of pulmonary exacerbation (fixed effects model, two parallel group RCTs and one cross-over trial: relative risk (RR) 0.25, (95 % confidence interval (95 % CI) 0.15,0.41); p < 0.00001; level of evidence: low) and decrease in fecal calprotectin (FCLP) levels (fixed effect model, three RCTs: mean difference (MD) -16.71, 95 % CI -27.30,-6.13); p = 0.002; level of evidence: low) after probiotic supplementation. Probiotic supplementation significantly improved gastrointestinal symptoms (one RCT, one non-RCT) and gut microbial balance (decreased Proteobacteria, increased Firmicutes, and Bacteroides in one RCT, one non-RCT).Conclusion: Limited low-quality evidence exists on the effects of probiotics in children with CF. Well-designed adequately powered RCTs assessing clinically meaningful outcomes are required to study this important issue.What Is Known: • Gut dysbiosis is frequent in children with cystic fibrosis due to frequent exposure to pathogens and antibiotics. • Probiotics decrease gut dysbiosis and improve gut maturity and function. What is New: • This comprehensive systematic review shows that current evidence on the safety and efficacy of probiotics in children with cystic fibrosis is limited and of low quality. • Well-designed and adequately powered trials assessing clinically important outcomes are required considering the health burden of cystic fibrosis and the potential benefits of probiotics. [ABSTRACT FROM AUTHOR]

Unlabelled: The objective of this study was to assess the feasibility of monitoring stress responses in newborns during naso-tracheal intubation after two different premedication regimens, using skin conductance measurements (SCM). Twenty-two newborns were randomised and premedicated with morphine + vecuronium or propofol. SCM (peaks/s) were collected prior to, during and after the procedure. Threshold for interpreting responses as stressful was 0.21 peaks/s. Intubation conditions and physiological parameters were registered. Intubation conditions were good in all newborns. Administration of morphine (range 1.4-10.3 min) before administration of vecuronium did not affect SCM when a stressful stimulus was applied. Within 1.6 min (range 0.8-3 min) after administration of vecuronium, SCM disappeared in 10 of 11 newborns. Propofol reduced SCM in 10 of 11 newborns at the first attempt. Further attempts were associated with increasing SCM, mostly above a threshold of 0.21 peaks/s. There were no significant changes in physiological parameters during the procedure for either premedication regimen.Conclusion: The variation in SCM between individual newborns limits the usefulness of SCM as stress monitor during intubation. The use of neuromuscular blockers for premedication precludes monitoring of SCM completely in newborns.What Is Known: Skin conductance measurements have been used successfully to monitor pain in awake newborn infants.What Is New: Premedicated newborns display significant interindividual variation in skin conductance measurements during an intubation procedure. Neuromuscular blockade causes skin conductance measurements to disappear completely. [ABSTRACT FROM AUTHOR]

Unlabelled: The aim of the present study was to evaluate whether the TruView video laryngoscope (TruView) facilitates pediatric endotracheal intubation (ETI) more quickly and safely than conventional Macintosh laryngoscope (MAC) in three manikin-based airway scenarios. This was a randomized crossover manikin study including 120 novice paramedics. The participants performed tracheal intubations using both TruView and MAC on a pediatric manikin in a control scenario (A), chest compression scenario (B), and chest compression cervical stabilization scenario (C). The sequence of scenarios was randomized. The primary outcome was time to intubation. Secondary outcomes were overall success rates, incidence of dental trauma, and ease of intubation. All intubation attempts were assessed by a trained assistant. The overall success rate was significantly higher with the TruView compared than the MAC in scenario B (100 vs. 81.7 %; p = 0.011) and scenario C (100 vs. 68.3 %; p < 0.001). The intubation time was significantly lower with the TruView than the MAC (18.5 vs. 24.3 s, p = 0.017, for scenario A; 21.6 vs. 25.7 s, p = 0.023, for scenario B; and 28.9 vs. 45.4 s, p < 0.001, for scenario C). Glottic view quality was better with TruView than the MAC in all scenarios, p < 0.001.Conclusions: The TruView offers better intubation conditions than the MAC on a pediatric manikin in the control scenario, chest compression scenario, and chest compression scenario with cervical stabilization scenario. The TruView may be used to elevate the epiglottis for orotracheal intubation. Further clinical studies are necessary to confirm these initial positive findings.Trial Registration: clinicaltrials.gov Identifier: NCT02289872.What Is Known: •Prehospital pediatric intubation using a standard laryngoscope is varied and ranges from 63.4 to 82 %. What is New: •This is the first study showing efficiency of pediatric endotracheal intubation using the TruView PCD by paramedics in tree simulation scenarios. •TruView PCD offers better pediatric intubation conditions than the Macintosh laryngoscope. [ABSTRACT FROM AUTHOR]

Unlabelled: The objective of the study was to compare the effect of umbilical cord milking (UCM) and delayed cord clamping (DCC) on hematological parameters (serum ferritin and hemoglobin) at 6 weeks of life in term neonates. It was a randomized controlled trail conducted at a teaching hospital in North India during August 2012 to August 2013. Babies born at >36 weeks of gestation were randomized in two groups, UCM and DCC (100 in each group). Umbilical cord milking was done after cutting and clamping the cord at 25 cm from the umbilicus. In DCC group, clamping was delayed by 60 to 90 s before cutting the cord. The baseline characteristics were comparable in the two groups. Mean serum ferritin (134.0 ng/ml [89.8]) and mean hemoglobin (11.0 gm/dl [2.4]) in umbilical cord milking group was comparable to mean serum ferritin (142.7 ng/ml [87.1]) and hemoglobin (11.3 gm/dl [2.6]) in DCC group at 6 weeks of age. There was no difference in hemodynamic status, cranial Doppler indices, and adverse neonatal outcomes among the two groups.Conclusion: In term neonates, the DCC and UCM had comparable effect on hematological parameters at 6 weeks of life.What Is Known: • Delayed cord blood clamping improves certain hematologic parameters for neonates, which is potentially important in populations with high rates of neonatal and childhood anemia, but that delayed cord blood clamping may not be feasible in clinical situations when neonatal resuscitation is urgent.What Is New: • There is no significant difference in ferritin and hemoglobin levels at 6 weeks among term, Indian neonates who had UCM and DCC and that this study may give support to the practice of UCM in term deliveries when DCC is not feasible. [ABSTRACT FROM AUTHOR]

We aimed to systematically evaluate evidence on the effectiveness of Lactobacillus reuteri DSM 17938 ( L. reuteri) for treating and preventing diseases in infants and children. MEDLINE and the Cochrane Library were searched in December 2013, with no language restrictions, for relevant randomized controlled trials (RCTs) and meta-analyses. The search was updated in April 2014. One systematic review and 14 RCTs met the inclusion criteria. The use of L. reuteri may be considered in the management of acute gastroenteritis as an adjunct to rehydration. There is some evidence that L. reuteri is effective in reducing the incidence of diarrhea in children attending day care centers. There is no evidence of effectiveness of L. reuteri in preventing nosocomial diarrhea in children. The administration of L. reuteri is likely to reduce crying time in infants with infantile colic in exclusively or predominantly exclusively breast-fed infants, but not in formula-fed infants. More studies are needed. Preliminary data suggest that L. reuteri may be effective in the prevention of some functional gastrointestinal disorders, such as colic and regurgitation. This innovative approach needs further evaluation by an independent research team. Preliminary evidence provides a rationale for further assessing the efficacy of L. reuteri for treating functional constipation or functional abdominal pain. However, it is too soon to recommend the routine use of L. reuteri for these conditions. There are no safety concerns with regard to the use of L. reuteri in nonimmunocompromised subjects. There are also data to support the safety of using L. reuteri in preterm infants. Conclusion: Our results precisely define current evidence on the effects of the administration of L. reuteri DSM 17938 to the pediatric population. [ABSTRACT FROM AUTHOR]

Chest physiotherapy (CP) using passive expiratory manoeuvres is widely used in Western Europe for the treatment of bronchiolitis, despite lacking evidence for its efficacy. We undertook an open randomised trial to evaluate the effectiveness of CP in infants hospitalised for bronchiolitis by comparing the time to clinical stability, the daily improvement of a severity score and the occurrence of complications between patients with and without CP. Children <1 year admitted for bronchiolitis in a tertiary hospital during two consecutive respiratory syncytial virus seasons were randomised to group 1 with CP (prolonged slow expiratory technique, slow accelerated expiratory flow, rarely induced cough) or group 2 without CP. All children received standard care (rhinopharyngeal suctioning, minimal handling, oxygen for saturation ≥92%, fractionated meals). Ninety-nine eligible children (mean age, 3.9 months), 50 in group 1 and 49 in group 2, with similar baseline variables and clinical severity at admission. Time to clinical stability, assessed as primary outcome, was similar for both groups (2.9 ± 2.1 vs. 3.2 ± 2.8 days, P = 0.45). The rate of improvement of a clinical and respiratory score, defined as secondary outcome, only showed a slightly faster improvement of the respiratory score in the intervention group when including stethoacoustic properties ( P = 0.044). Complications were rare but occurred more frequently, although not significantly ( P = 0.21), in the control arm. In conclusion, this study shows the absence of effectiveness of CP using passive expiratory techniques in infants hospitalised for bronchiolitis. It seems justified to recommend against the routine use of CP in these patients. [ABSTRACT FROM AUTHOR]

In Switzerland, children are prescribed 7.5-12.5 μg per day of vitamin D(3) dissolved in alcohol, but many families do not adhere to the recommendation. The aim of the trial was to compare the acceptance of vitamin D(3) dissolved in alcohol or in medium-chain triglycerides among mothers of Swiss newborn infants. The acceptance was tested in 42 healthy newborn infants (20 girls and 22 boys) aged between 2 and 7 days. Their neonatal body weight ranged between 2.225 and 4.150 kg, and the gestational age between 36 1/7 and 41 3/7 weeks. The blinded mothers rated the facial reaction of their children by pointing on a facial hedonic scale. Thirty eight of the 41 mothers, who brought the comparison to completion, assigned a better score to the oily preparation with no difference in the remaining three cases (P < 0.0001). The acceptance for the oily preparation was significantly better both among mothers whose babies were initially presented the alcoholic preparation and among mothers whose babies were initially presented the oily preparation. Furthermore, the acceptance for the oily preparation was better irrespective of gender of the infant or parity of the mother. In conclusion, from the perspective of mothers, Swiss newborn infants prefer the taste of the oily vitamin D(3) preparation over the alcoholic preparation. [ABSTRACT FROM AUTHOR]

Phototherapy is the standard treatment in moderately severe hemolytic disease of newborn (HDN), whereas exchange transfusion (ET) is the second line in progressive cases. Intravenous immunoglobin (IVIG) has been suggested to decrease the need for ET. We aimed at assessing the efficacy of early two-dose regimens of IVIG to avoid unnecessary ET in severe Rh HDN. The study included 90 full-term neonates with Rh incompatibility unmodified by antenatal treatment and not eligible for early ET and which were randomly assigned into one of three groups: group (I), treated by conventional method; groups IIa and IIb received IVIG once at 12 h postnatal age if PT was indicated, in a dose of 0.5 and 1 g/kg, respectively. Analysis revealed 11 neonates (22%) in the conventional group and 2 (5%) in the intervention group who administered low-dose IVIG at 12 h, while none in group IIb required exchange transfusion (p = 0.03). Mean bilirubin levels were significantly lower during the first 96 h in the intervention group compared to the conventional group (p < 0.0001). Shorter duration of phototherapy (52.8 ± 12.39 h) and hospital stay (3.25 ± 0.71 days) in the IVIG group compared to conventional group (84 ± 12.12 h and 4.72 ± 0.78 days, p < 0.0001, respectively) were observed. We conclude that IVIG administration at 12 h was effective in the treatment of severe Rh HDN; the low-dose IVIG (0.5 g/kg) was as effective as high dose (1 g/kg) in reducing the duration of phototherapy and hospital stay, but less effective in avoiding exchange transfusion. [ABSTRACT FROM AUTHOR]

Animal studies suggest that administration of vitamin A to rats with experimental urinary tract infection decreases the frequency of renal scars (Kavukçu et al., BJU Int 83(9):1055-1059, 1999). The aim of this study was to determine the effect of vitamin A on the rate of permanent renal damage in children with acute pyelonephritis. Fifty children, median age of 24 months (range 2-144), with first-time pyelonephritis verified by an uptake defect on acute dimercaptosuccinic acid (DMSA) scan were included in the study and randomly allocated to the case or control groups. All were given intravenous ceftriaxone for 10 days followed by oral cephalexin for 3 months. Cases in addition were given a single intramuscular dose of vitamin A, 25,000 U for infants below 1 year of age and 50,000 U for older children. At the repeat DMSA scan after 3 months, five of 25 cases (20%) and 17 of 25 controls (68%) had abnormal findings (p = 0.001). In conclusion, administration of vitamin A was associated with a significantly lower rate of permanent renal damage. [ABSTRACT FROM AUTHOR]

The risk of upper respiratory infections (URIs) is increased in people who are under heavy physical stress, including recreational and competitive swimmers. Additional treatment options are needed, especially in the younger age group. The aim of this study was to determine whether 1 g/day vitamin C supplementation affects the rate, length, or severity of URIs in adolescent swimmers. We carried out a randomized, double-blind, placebo-controlled trial during three winter months, among 39 competitive young swimmers (mean age 13.8 ± 1.6 years) in Jerusalem, Israel. Vitamin C had no effect on the incidence of URIs (rate ratio = 1.01; 95% confidence interval (CI) = 0.70-1.46). The duration of respiratory infections was 22% shorter in vitamin C group, but the difference was not statistically significant. However, we found a significant interaction between vitamin C effect and sex, so that vitamin C shortened the duration of infections in male swimmers by 47% (95% CI: −80% to −14%), but had no effect on female swimmers (difference in duration: +17%; 95% CI: −38% to +71%). The effect of vitamin C on the severity of URIs was also different between male and female swimmers, so that vitamin C was beneficial for males, but not for females. Our study indicates that vitamin C does not affect the rate of respiratory infections in competitive swimmers. Nevertheless, we found that vitamin C decreased the duration and severity of respiratory infections in male swimmers, but not in females. This finding warrants further research. [ABSTRACT FROM AUTHOR]

We aimed to evaluate a family-oriented psycho-educational asthma training program for the age group of 2-5 years, involving both parents and children. Children were included after having at least 3 obstructive episodes in their life plus chronic or recurrent wheeze in the 6 months before the start of the study. In the multicenter randomized trial we had (1) a waiting group (WG), (2) an instruction group (IG) trained in a structured way according to the national asthma guideline, and (3) an education group (EG), having a standardized multiprofessional psycho-educational program, according to the national licensed asthma education for the age group of 6-18 years. All were assessed after 6 months. A subgroup analysis was performed on those being on regular inhaled corticosteroids at study entry (74.3%). A total of 338 children were randomized, and 288 (85%) completed the study. In the asthma emergency management, test scores increased most in EG, less in IG, and not in WG. For emergency visits the risk ratio for EG was 0.68 compared to IG: Patients regularly inhaling corticosteroids (74.3%) had an increased risk for emergency visits when having only an instruction (OR 3.99 [1.89-8.40]) or had been waiting (OR 2.5 [1.16-5.37]) when compared to those having an asthma education. We conclude that in the German health system, the family oriented psycho-educational program provided in a standardized manner by a multiprofessional team is effective also in the age group of 2-5 years. It should be made accessible to each asthmatic child. [ABSTRACT FROM AUTHOR]

Attention deficit/hyperactivity disorder (ADHD), a common behavioural disorder in children, may be associated with comorbid physical and sleep complaints. Dietary intervention studies have shown convincing evidence of efficacy in reducing ADHD symptoms in children. In this pilot study, we investigated the effects of an elimination diet on physical and sleep complaints in children with ADHD. A group of 27 children (3.8–8.5 years old), who all met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for ADHD, were assigned randomly to either a diet group (15/27) or a control group (12/27). The diet group followed a 5-week elimination diet; the control group adhered to their normal diet. Parents of both groups had to keep an extended diary and had to monitor the behaviour and the physical and sleep complaints of their child conscientiously. The primary endpoint was the clinical response, i.e. a decrease of physical and sleep complaints, at the end of the trial, based on parent ratings on a Physical Complaints Questionnaire. The number of physical and sleep complaints was significantly decreased in the diet group compared to the control group ( p < 0.001), with a reduction in the diet group of 77% ( p < 0.001, effect size = 2.0) and in the control group of 17% ( p = 0.08, effect size = 0.2). Specific complaints that were significantly reduced were in three domains: headaches or bellyaches, unusual thirst or unusual perspiration, and sleep complaints. The reduction of complaints seemed to occur independently of the behavioural changes ( p = 0.1). However, the power of this comparison was low. A positive correlation existed between the reduction of physical and behavioural symptoms ( p < 0.01). The reduction did not differ between children with or without an atopic constitution ( p = 0.7). An elimination diet may be an effective instrument to reduce physical complaints in children with ADHD, but more research is needed to determine the effects of food on (functional) somatic symptoms in children with and without ADHD. This trial was registered as an International Standard Randomised Controlled Trial, ISRCTN47247160. [ABSTRACT FROM AUTHOR]

The butyrophilin-like 2 (BTNL2) gene is a member of the B7 receptor family that probably functions as a T cell costimulatory molecule. Because altered T cell functions are implicated in dysregulation of the immune response seen in Kawasaki disease (KD), it is reasonable to speculate that BTNL2 gene is involved in the pathophysiology of KD. The purpose of this study was to investigate whether polymorphisms of the BTNL2 gene are associated with KD and the development of coronary artery lesions (CALs) in Taiwanese children. Nine-three patients with KD and 669 ethnically matched healthy controls were genotyped for BTNL2 gene rs1555115 C/G and rs2395158 A/G polymorphisms. The frequency of GG genotype of rs 1555115 was significantly higher in KD patients compared with controls (2.2% vs 0.2%, P = 0.012). The odds ratio for developing KD in individuals with rs 1555115 GG genotype was 14.7 (95% confidence interval, 2.04-105.5, P = 0.003) compared with individuals with rs 1555115 CG and CC genotypes. No significant difference was observed in the genotype and allelic frequencies of rs 2395158 polymorphism between KD patients and controls. However, the frequency of the G allele of rs 2395158 was significantly higher in KD patients with CALs than in those without CALs (P = 0.001). No significant difference was observed in the genotype and allelic frequencies of rs 1555115 polymorphism between KD patients with and without CALs. In conclusion, our results suggest that BTNL2 gene polymorphisms might be genetic markers of KD susceptibility and risk of coronary artery complication in Taiwanese children. [ABSTRACT FROM AUTHOR]

Introduction: This study investigated the effect of combined exercise training on indices of body composition, physical fitness and lipid profile in adolescents with mental retardation.Materials and Methods: Thirty adolescents with mental retardation (total IQ, 45-70) received exercise training (n = 15) or no training (n = 15). Groups were matched for age, sex and mental retardation. Before and after the intervention period, indices of body composition, physical fitness and lipid profile were measured.Results: In comparison with the control group, weight, body mass index, waist and fat mass decreased significantly, while relative fat-free mass increased. The level of triglycerides, total cholesterol and low-density lipoprotein decreased significantly, while high-density lipoprotein increased. Muscle strength, muscle fatigue resistance and sit-to-stand were ameliorated. PeakVO2/peak power decreased significantly. The distance covered in the 6-min walk test (6MWT) increased with 50 m.Conclusion: In conclusion, combined exercise training has a positive effect on indices of obesity, physical fitness and lipid profile in adolescents with mental retardation. [ABSTRACT FROM AUTHOR]

The effect of increased recreational physical activity in children on insulin levels has not yet been studied. We carried out a randomized controlled trial in 76 children 6-9 years old, 32 of them increased their physical activity and 30 maintained the same level. In the intervention group, after a week of baseline, recreational activity three times/week was programmed for 12 weeks. We compared insulin, homeostatic model assessment (HOMA) index, glucose, HDL-C, LDL-C, triglycerides, and body mass index in both groups. Thereafter, we compared groups of normal weight, overweight, and with obesity in the experimental group. The group of recreational activity increased their median daily steps (15,329 to 19,910) and decreased insulin (p < 0.001) and HOMA index (4.36 vs. 2.39, p < 0.001). The diminution of insulin levels was more significant in the overweight group (p < 0.007). In conclusion, in our group, children who increased physical activity during 12 weeks decrease insulin levels and insulin resistance without change in other metabolic and anthropometric variables. [ABSTRACT FROM AUTHOR]

Introduction: This study assessed the short- and long-term effects of a 3-month family-based group treatment in the management of childhood obesity versus individual treatment.Materials and Methods: Eighty obese children, aged between 6 and 14 years, and their parents were included in this prospective controlled clinical study. Forty participants were randomly assigned for group treatment and the other 40 for individual treatment. A 3-month intervention program was focused on implementing healthy eating behaviors. The weight and height of the children were measured initially and at each treatment session and at follow-up visits. Body mass index was calculated and expressed as standard deviation score.Results and Discussion: At the end of 3-month treatment program, there was a significant decline in BMI SDS in both groups (p < 0.001). After 1 year of follow-up period, there was still a significant decrease in BMI SDS in the study group (p < 0.001), whereas the decrease in BMI SDS was not maintained over the follow-up period in the standard group. There was a significantly increased consumption of vegetable and fruit and reduced consumption of carbonated drinks and fruit juice in both groups (p < 0.001).Conclusion: These findings demonstrate that the group treatment is more successful than the individual treatment in the management of childhood obesity. [ABSTRACT FROM AUTHOR]

Unlabelled: This is a comparative study between 60 asphyxiated newborns (cases) and 60 normal neonates (controls) in respect of their plasma glucose and uric acid levels and also their clinical and neurological status. The mean plasma glucose level was significantly lower (35.1 +/- 11.4 mg/dl vs. 56.9 +/- 5.5 mg/dl; P < 0.001) and the mean serum uric acid level was higher (8.0 +/- 1.2 mg/dl vs. 4.5 +/- 0.83 mg/dl; P < 0.001) in the asphyxiated group when compared to the controls. Within the perinatal asphyxia group, the plasma glucose level and Apgar scores showed a significant positive linear correlation (r = 0.740, P < 0.001), whereas a significant negative linear correlation was observed between the glucose level and different stages of hypoxic ischemic encephalopathy (HIE) (r = -0.875, P < 0.001). Although a strong positive linear correlation was found between uric acid and HIE stages (r = 0.734, P < or = 0.001), the linear correlation between uric acid and Apgar scores (r = -0.885, P < 0.001) and uric acid and the plasma glucose level (r = -0.725, P < 0.001) were found to be significantly negative among the cases.Conclusion: The severity of encephalopathy and cellular damage varies with the severity of hypoglycemia. [ABSTRACT FROM AUTHOR]

This study aimed to determine the effects of intravenous methylprednisolone pulse (IVMP) therapy on cytokine levels in patients with acute Kawasaki disease (KD) unresponsive to initial intravenous immunoglobulin (IVIG) therapy. Fifteen KD patients unresponsive to initial IVIG, 2 g/kg/day, were randomized to receive IVMP (n = 7), 30 mg/kg/day for 3 days or additional IVIG (n = 8), 2 g/kg/day, and plasma cytokine levels were compared. The fraction of febrile patients was significantly lower in the IVMP group than in the additional IVIG group on day 2 (0/7 vs. 3/8, p = 0.03), but not on day 4 and later (3/7 vs. 4/8, p = 1.00) because of recurrent fever. The prevalence of coronary lesions was similar between the two groups (2/7 vs. 2/8, p = 1.00). The ratios of plasma levels of tumor necrosis factor-alpha and monocyte chemoattractant protein-1 to those at enrollment (defined as day 1) were significantly lower in the IVMP group on day 4 (0.50 +/- 0.27 vs. 1.01 +/- 0.46, 0.53 +/- 0.39 vs. 0.93 +/- 0.44, p = 0.02 and 0.045, respectively), but not on day 7 (0.54 +/- 0.34 vs. 0.88 +/- 0.39, 0.76 +/- 0.39 vs. 0.61 +/- 0.17, p = 0.07 and 0.83, respectively). The ratios of interleukin-2 receptor, interleukin-6, and vascular endothelial cell growth factor to those at enrollment did not differ significantly between the two groups. In conclusion, for KD patients unresponsive to initial IVIG, IVMP suppresses cytokine levels faster, but subsequently similarly, compared with additional IVIG. [ABSTRACT FROM AUTHOR]

The aim of our study was to evaluate whether high-intensity gallium nitride light-emitting diode (LED) phototherapy (LPT) influences transepidermal water loss (TEWL) and cerebral hemodynamics in preterm neonates in comparison with conventional phototherapy (CPT). Thirty-one preterm infants were randomized for conventional (n = 14) and for LED (n = 17) phototherapy. All infants were studied using a Tewameter TM 210 and cerebral Doppler ultrasound immediately before phototherapy (time 0), 30 min (time 1), 1-6 h (time 2), and 12-24 h (time 3) after the start of phototherapy, and 6-12 h after discontinuing phototherapy (time 4). The study shows that LPT does not induce significant changes in TEWL (time 0: 2.75 +/- 4.71 ml/m(2)/h; time 3: 14.45 +/- 3.68 ml/m(2)/h), in peak systolic, end diastolic and mean cerebral blood flow velocity (CBFV), and in the resistence index (RI). On the contrary, CPT is associated with a significant increase of TEWL (time 0: 13.22 +/- 5.61 ml/m(2)/h; time 3: 20.94 +/- 3.21 ml/m(2)/h), which disappeared at time 4, when phototherapy had stopped. The peak systolic and mean CBFV increased, respectively, from 0.11 +/- 0.03 m/s at time 0 to 0.16 +/- 0.07 m/s at time 3. We conclude that LPT, emitting light within the 450-470-nm spectrum for optimal bilirubin degradation, can be preferable to CPT for the therapy of hyperbilirubinemia in preterm infants. [ABSTRACT FROM AUTHOR]

Reduced-antigen-content pertussis vaccines designed initially for booster vaccination of adolescents and adults can also be used to vaccinate pre-school age children. Combination vaccines, which reduce the number of administered injections, combine multiple antigens including inactivated poliovirus (IPV), which is recommended in this age group in some countries. This randomised, controlled study compared a combined diphtheria-tetanus-acellular pertussis-inactivated polio-containing booster vaccine, dTpa-IPV (Boostrix Polio, n=822), to separately administered dTpa (Boostrix) and IPV (IPV Mérieux, n=136) in 4-8-year-old children who had previously received four doses of DTPa. Additional serological assessment was performed 1 year after the booster dose. One month after vaccination, seroprotection/vaccine response rates were similar for both groups. At least 99.9% of the subjects had protective antibodies against diphtheria, tetanus and polio, and at least 90.1% had a vaccine response to pertussis antigens after dTpa-IPV. Reactogenicity of dTpa-IPV was comparable to dTpa + IPV. Fever and grade 3 loss of appetite occurred more commonly after dTpa-IPV, whereas swelling and grade 3 pain occurred more frequently after separately administered dTpa + IPV (P<0.05 for all). However, 95% CIs overlapped in all cases. Large swelling reactions after dTpa-IPV occurred less commonly than have been reported after a fifth dose of DTPa. One year after the booster, 98.6% of the subjects tested continued to have protective antibodies against diphtheria, tetanus and polio, and at least 81.2% were seropositive for pertussis components. The reduced-antigen-content dTpa-IPV vaccine was immunogenic, well tolerated and safe in pre-school age children. It provides immunity against four diseases in a single injection, with the potential reactogenicity benefit of a reduced-antigen dose. [ABSTRACT FROM AUTHOR]

Unlabelled: In this double-blind randomised placebo-controlled trial it was investigated during a two-year follow-up whether oral bisphosphonates (Olpadronate 10 mg/m2/day) influence quality of life in children with osteogenesis imperfecta (OI). Thirty-four children with OI (classified according to Sillence criteria), aged 3 to 18 years of age, with a restricted level of ambulation were included. Randomisation was performed using a list of computer generated random numbers to allocate patients to receive Olpadronate or placebo. Quality of life was measured using self-perception profile for children (SPPC) and health-utility index (HUI). Differences between baseline measurements and measurements at two years follow-up were analysed within the Olpadronate and placebo group using a student's t-test. Differences in HUI and SPPC regression coefficients were analysed by random-effects repeated measures analysis (SAS, Proc Mixed, version 8.2), adjusted for age, gender and type of OI. Within the Olpadronate group there was a significant decrease in pain utility; however, difference in six months' regression coefficients between the placebo and Olpadronate group were not significant. Within the placebo group there was a significant increase in scholastic competence and behavioural conduct. The item behavioural conduct showed a steeper annual regression coefficient favourable for the placebo group. In the other SPPC items none of the annual regression coefficients showed a significant difference between the Olpadronate and the placebo group.Conclusion: We found only slight differences in quality of life in favour of the bisphosphonate group. A small but not significant decrease in pain was detected in the bisphosphonate group. [ABSTRACT FROM AUTHOR]

This study was undertaken to assess the co-administration of an experimental measles-mumps-rubella-varicella vaccine (MMRV, GlaxoSmithKline Biologicals) with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate (DTPa-HBV-IPV/Hib) vaccine in healthy children. Healthy children aged 12-23 months (N = 451) were randomised to one of three parallel groups to receive one dose of MMRV vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine (co-administration group), or one dose of MMRV vaccine alone (MMRV group), or a booster dose of DTPa-HBV-IPV/Hib vaccine alone (DTPa-HBV-IPV/Hib group). No differences in seroconversion rates for measles (>95%), mumps (>80%), rubella (>99%) and varicella (>98%) were seen between the co-administration group and the MMRV group. No differences in geometric mean titres (GMTs) were observed between the two groups with the exception of anti-measles titres, which were observed to be higher in the MMRV group than in the co-administration group (4,419.2 vs. 3,441.8 mIU/ml respectively). Immune response to the booster dose of DTPa-HBV-IPV/Hib vaccine was observed to be similar in the co-administration group and the DTPa-HBV-IPV/Hib group. Co-administration of the MMRV vaccine with a booster dose of DTPa-HBV-IPV/Hib vaccine was well-tolerated and did not exacerbate the reactogenicity profile of either vaccine. In summary, GlaxoSmithKline Biologicals' experimental MMRV vaccine was immunogenic and well-tolerated when administered with a booster dose of DTPa-HBV-IPV/Hib vaccine during the second year of life. The ability to co-administer the MMRV vaccine at the same time as other routine childhood immunisation vaccines could increase compliance with varicella vaccination in countries where this vaccine is already recommended and may facilitate implementation of varicella vaccination elsewhere. [ABSTRACT FROM AUTHOR]

Introduction: This randomised, observer-blind clinical trial conducted in Turkey evaluated the immunogenicity, safety and interchangeability of three paediatric inactivated hepatitis A vaccines in 424 seronegative children between 1 and 15 years of age.Methods: Potential subjects were screened for anti-hepatitis A virus (HAV) antibodies prior to receiving a first dose of Avaxim 80, Havrix 720 or Vaqta 25, followed by a second dose of either the same vaccine or Avaxim 6 months later. Anti-HAV antibody concentrations were measured 2 weeks after the first injection, at 24 weeks (before the second dose) and at 28 weeks for the evaluation of the immune response.Results: Nearly 80% of the children between 1 and 5 years of age and half of those between the ages of 6 and 10 in the population from which the subjects were recruited were seronegative for HAV antibodies. Two weeks after the first dose, 98.2% of all subjects had anti-HAV antibody concentrations equal to or higher than 20 mIU/mL, believed to be seroprotective, and all subjects were seroprotected before and after the second dose. Anti-HAV geometric mean concentrations (GMCs) 2 weeks after the first dose and before the second were similar in children who received Avaxim and Vaqta (P = 0.2), but both were higher than Havrix (P < 0.01). There were no significant differences in the anti-HAV GMCs between the study groups that received two doses of the same vaccine compared with two doses of different vaccines. There were no significant differences in the frequency of any local or systemic adverse events among the study groups following either of the two doses.Conclusion: All three vaccines are safe and highly immunogenic in healthy children aged 1 to 15 years. Avaxim 80 may also be given as the second dose when Havrix 720 or Vaqta 25 are given as the first dose. The pattern of seroprevalence seen here is similar to that reported in a number of recent evaluations in Turkey, and are supportive of the routine hepatitis A vaccination of young children. [ABSTRACT FROM AUTHOR]

A single, 2 g/kg dose of immune globulin (IG), denoted 2 g-intravenous (IV)IG, has become a standard regimen for treating Kawasaki disease (KD) because of its highly preventive effect on coronary arterial lesions (CAL). However, IG is obtained from blood specimens, a drawback to many patients, and is also very expensive. This randomized prospective study reported here was carried out with the aim of developing a treatment regimen that would reduce the total dose of IG. The study tested two protocols (A: 2 g-IVIG; B: 1 g-IVIG) that included the strategy of administering additional IVIG to IVIG-resistant patients based on the criteria we described previously. In protocol A, an additional 2 g-IVIG was administered only once; in protocol B, the first additional IVIG was 1 g-IVIG and the second was 2 g-IVIG. One hundred and nine patients who were admitted before the seventh day of illness and had no CAL at the time of admission were enrolled in the study (protocol A: 54 patients; B: 55 patients). In the protocol A group, 7.4% (4/54) of the patients received 4 g/kg IG. In protocol B, 41.8% (23/55) were treated only with 1 g/kg IG, and 10.9% (6/55) received 4 g/kg IG. No significant differences were observed between the patients of the two subgroups receiving 4 g/kg IG in each protocol group. Discriminate analysis also suggested that 52.4% of the patients in the protocol A group could be treated only with 1 g/kg IG. On the other hand, no significant difference was observed in the incidence of aneurysms between patients in the protocol A group (1/54) and those in the protocol B group (4/55). Our protocol based on 1 g-IVIG, including additional IVIG, was assessed to be an effective treatment and to provide a considerably useful means to reduce the total dose of IG. [ABSTRACT FROM AUTHOR]