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Objective We describe a case of severe hypoglycemia in a 14-month-old child as a suspected adverse drug reaction (ADR) to nadolol, and we performed an analysis of the FDA Adverse Event Reporting System (FAERS) database. Although previous reports have identified the risk of severe hypoglycemia in children during treatment with β-blockers, little is known about hypoglycemia as an ADR in infants treated with nadolol. Moreover, the pharmacodynamic and pharmacokinetic profiles of nadolol in children aged less than 1 year old are still not fully known. Materials and methods We extracted all ADR reports involving nadolol from the FAERS database; in order to reduce the risk of bias, we only considered cases that exclusively reported nadolol as the suspect drug. We then selected cases of hypoglycemia in the pediatric population and conducted a manual deduplication. Results Upon FAERS database analysis, a total of 2,674 suspected ADR reports to nadolol were found. Of these, 1,950 (73%) were solely attributed to nadolol, and 63 of them were hypoglycemic events. A total of 47 reports included the relevant pediatric age (74.6%). After deduplication, we identified 25 cases (mean age: 3.65 years old); all of these reports were categorized as serious, and hospitalization was required in 15 cases. Conclusion Hypoglycemia is a reported life-threatening ADR associated with nadolol, especially in infants, in whom this drug should be used with caution.

AIMS To investigate the statistical association between hypoglycaemia and β-blocker use and to define what patient and drug characteristics could potentially increase the risk for its occurrence. METHODS We investigated the relationship between pharmacological parameters of β-blockers and the occurrence of hypoglycaemia by conducting a case/non case analysis using the Food and Drug Administration Adverse Event Reporting System database. Pharmacological properties that could represent a predictive factor for hypoglycaemia were analysed through a multilinear binary logistic regression (null hypothesis rejected for values of P < .05). We also performed a systematic review of clinical studies on this association. RESULTS Of 83 954 selected reports, 1465 cases (1.75%) of hypoglycaemia were identified. The association was found statistically significant for nadolol (reporting odds ratio [95% confidence interval]: 6.98 [5.40-9.03]), celiprolol (2.35 [1.35-4.10]), propranolol (2.14 [1.87-2.46]) and bisoprolol (1.42 [1.25-1.61]). Paediatric cases (n = 310) showed a positive association with hypoglycaemia for long half-life drugs (odds ratio [95% confidence interval]: 2.232 [1.398-3.563]) and a negative association for β1-selectivity (0.644 [0.414-0.999]). Seven papers were included in the systematic review. Because of great heterogeneity in study design and demographics, hypoglycaemia incidence rates varied greatly among studies, occurring in 1.73% of the cases for propranolol treatment (n total participants = 575), 6.6% for atenolol (n = 30) and 10% for carvedilol (n = 20). CONCLUSION Nadolol appears to be the β-blocker significantly most associated with hypoglycaemia and children represent the most susceptible sample. Furthermore, long half-life and nonselective β-blockers seem to increase the risk for its occurrence.

Obesity has been associated with several alterations that could limit physical activity (PA) practice. In pediatrics, some studies have highlighted the importance of enjoyment as a motivation to begin and maintain adherence in PA. Since self-reported physical (SRPF) fitness was related to motivation, the aim of this study was to investigate the existence of differences between SRPF in children with obesity (OB) compared to normal weight (NW). The International Fitness Enjoyment Scale (IFIS) questionnaire was administered to 200 OB and 200 NW children. In all the subjects, height, weight, and BMI and in OB children adiposity indexes including waist circumference (WC), body shape index (ABSI), triponderal mass index (TMI), and fat mass were measured. NW group showed higher IFIS item scores than the OB group (p &lt, 0.01), except in muscular strength. In OB, the anthropometric outcomes were inversely correlated to SRPF outcome except for muscular strength. OB children reported a lower perception of fitness that could limit participation in PA/exercise programs. The evaluation of anthropometric patterns may be useful to prescribe a tailored exercise program considering individual better self-perception outcomes to obtain an optimal PA adherence.

Aim The use of probiotics has been covered by many guidelines, position papers and evidence‐based recommendations, but few have referred to specific patient groups or clinical indications. This review summarises recommendations and scientifically credited guidelines on the use of probiotics for children with selected clinical conditions and provides practice points. Methods An expert panel was convened by the European Paediatric Association in June 2017 to define the relevant clinical questions for using probiotics in paediatric health care and review and summarise the guidelines, recommendations, position papers and high‐quality evidence. Results The panel found that specific probiotic strains were effective in preventing antibiotic‐associated and nosocomial diarrhoea, treating acute gastroenteritis and treating infantile colic in breastfed infants. However, special caution is indicated for premature infants, immunocompromised and critically ill patients and those with central venous catheters, cardiac valvular disease and short‐gut syndrome. This review discusses the safety of using probiotics in selected groups of paediatric patients and the quality of the available products providing practice points based on proved findings. Conclusion Efficacy of probiotics is strain specific. Their benefits are currently scientifically proven for their use in selected clinical conditions in children and not recommended for certain patient groups.

Reduced bone mineral density (BMD) and altered bone metabolism are common findings in HIV-infected patients. Increased bone formation has been described both in HIV-infected adults and children. Wnt ligands promote bone formation by stimulating osteoblast differentiation and their survival. Sclerostin and dickkopf factor 1 (DKK-1), Wnt antagonists, are important negative regulators of bone formation. We studied 86 HIV-infected patients whose ages ranged from 5.7 to 27.9 years. Patients were all on antiretroviral therapy, but seven who were naive to treatment. Bone alkaline phosphatase (BAP), sclerostin, and DKK-1 were measured in serum by enzyme immunoassay. BMD was measured by dual-energy X-ray absorptiometry at the lumbar spine and in the whole skeleton. Biochemical indexes were also measured in 143 healthy controls (age range 4.5-27.4 years). HIV-infected patients had lower than normal BMD (spine P < 0.005, and whole skeleton P < 0.03). BAP measurements were significantly higher in HIV-infected patients than controls (P ≤ 0.05). Sclerostin and DKK-1 concentrations were markedly lower than in controls (P ≤ 0.0006, and P ≤ 0.03, respectively). The serum concentration of both analytes of patients naive to antiretroviral treatment was not different from that of treated patients. No correlations were found between sclerostin, DKK-1, and bone mineral measurements. Our data confirm the alteration of bone metabolism pathways in HIV-infected individuals. The lower concentration of Wnt antagonists is consistent with the increased bone formation markers.

Rotavirus vaccines have shown to be effective and well tolerated in clinical trials. However it's crucial to point out that immunization occurs in "real-word" conditions different from ideal clinical trial settings. Thus, the impact of rotavirus vaccines in terms of effectiveness and safety needs to be evaluated in real-world conditions. Post-licensure data regarding vaccine impact, effectiveness and safety under routine use are now available and provide a "real-world view". We reviewed published data about the impact of rotavirus vaccines in the post-licensure era.

Prescription of generic medicines represents an efficacious healthcare cost containment strategy. In some European countries and in the US, generic medicines are largely prescribed. In Italy, generic drugs prescription rate is lower. General Practitioners and Family Pediatricians may be less confident in prescribing generic equivalents instead of "branded" medicines. There are currently no data about Italian Family Pediatricians' perceptions and patterns of use of generic drugs. This is a first nationwide web survey conducted with the aim to evaluate generic medicines knowledge and prescribing habits of Italian Family Pediatricians. 303 Family Pediatricians completed the online questionnaire. 37.2% and 32.6% of them declared to have a sufficient or fairly good knowledge of generic medicines, respectively, and the majority of them believed that efficacy of generic medicines was sufficient (33.6%) or good (45.2%). Nevertheless, Italian Family Pediatricians are still prone to prescribe trade medicines more frequently, since only 13.5% of them declared that more than a half of their patients were treated with generic medicines. Major issues related with generic medicines prescriptions by Italian Family Pediatricians seem to be represented by diffuse scepticism about reliability of bioequivalence tests and safety of switchability from branded to generic equivalents. More information about generic drugs and more research in the field of pediatric pharmacology are needed for increasing generic medicines prescription rate among Italian Family Pediatricians.

In the past, immunization programs worldwide mainly focused on the delivery of infant and early childhood vaccines. An increasing awareness of the importance of investing in adolescents' health has led to the introduction of new vaccines targeted specifically to adolescents over the last ten years: this has improved the adolescent's opportunities to protect from certain diseases for which they are at an increased risk. Safe and effective vaccines against human papilloma virus, Neisseria meningitides and Bordetella pertussis are recommended in many parts of the world; nevertheless, vaccination coverage in this age group is relatively low compared to coverage in infants. Barriers to adolescent immuniza- tion are believed to be complex and multifactorial but overcoming these barriers will be of primary importance for the future.

Positional or deformational plagiocephaly is the most common type of cranial asymmetry in infancy and has become more prevalent after the introduction of the “Back to Sleep” campaign in Western countries. However, the supine position cannot be considered as the only etiologic factor and different predisposing variables have been investigated in the last few years. The pediatrician should correctly diagnose this condition and exclude the possibility of craniosynostosis in any child with plagiocephaly in order to optimize management and reduce potential morbidity associated with different conditions other than positional ones. In addition, the pediatrician needs to be able to educate parents on methods to proactively decrease the likelihood of the development of occipital flattening, initiate appropriate management, and make referrals when necessary.

More research is needed on the use of probiotics for critically ill patients

Epidemiological data suggests suicide is uncommon in childhood but becomes an extremely serious issue among adolescents. Several risk factors have been identified and include the presence of psychiatric illness, a previous suicide attempt, family factors, substance abuse, sexual and physical abuse, disorders in gender identity or bullying. Pediatricians have a primary role in searching for these risk factors, recognizing them and acting synergistically with other specialists to prevent and treat suicidal behavior. Pediatricians should also be able to identify the “warning signs” for suicide since their presence implies a need for immediate action, as attempted suicide may occur in a few hours or days. The use of antidepressant drugs and its association with suicidal risk in pediatric age is another topic of ongoing debate. Food and Drug Administration has recently introduced the so-called “black box” on antidepressants’ packages with the aim of gaining attention to the possible risk of suicide among adolescents who are treated with antidepressants, with a warning that the risk of suicide is higher when starting a therapy or while adjusting its dosage.

A 8 month-old infant presented with acute onset of severe jaundice, anemia requiring transfusion and Glucose-6-Phosphate Dehydrogenase deficiency. The infant did not take drugs, he did not consume fava beans, but fava beans DNA was found on pumpkin he consumed the day before jaundice onset. This is the first case of hemolysis triggered by ingestion of food cross-contaminated with fava beans.

This multicenter, prospective, observational study assessed the global economic impact of HIV care in a large cohort of HIV-infected children and adolescents in Italy. Three pediatric departments of reference participated on a voluntary basis. Centers were asked to enroll all their children during the period April 2010-March 2011. At enrollment, a pediatrician completed a questionnaire for each patient, including the type of service at access (outpatient consultation or day hospital), laboratory tests, instrumental examinations, specialists' consultations, antiretroviral therapy and opportunistic illness prophylaxis. Eligible patients had a confirmed diagnosis of HIV infection caused by direct vertical maternal-fetal transmission, their age ranging from 0 to 24 years. Since patients routinely have quarterly check-ups in all three centers, we adopted a three-month time horizon. Health-care services were priced using outpatient and inpatient tariffs. Drug costs were calculated by multiplying the daily dose by the public price for each active ingredient. A total of 142 patients were enrolled. More than half the patients were female and the mean age was 14 years, with no significant differences by center. There were substantial differences in health-care management among the three centers, particularly as regards the type of access. One center enrolled the majority of its patients in day-hospital and prescribed a large number of clinical tests, while children accessed another center almost exclusively through outpatient consultation. Drug therapy was the main cost component and was very similar in all three centers. The day-hospital was the second highest cost component, much higher than outpatient consultation (including examinations), leading to significant differences between total costs per center. These findings suggest that a recommendation to the Italian National Health Service would be to use more outpatient consultation for patients' access in order to increase their efficiency in treating pediatric HIV infection.

This is an 8-year cohort study of 24 HIV-infected patients aged 5–17 years to assess body composition and metabolic changes after switching from lamivudine + stavudine (d4T) + protease inhibitors (PI) to lamivudine + tenofovir (TDF) + efavirenz (EFV). Body composition (dual-energy X-ray absorptiometry) and cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, glucose and insulin were measured annually. Linear mixed models and generalized linear mixed models were used to evaluate time changes of the outcome of interest. Body mass index increased linearly by 0.3 kg/m2/year (p

Treatment with antiretroviral agents (ARVs) during pregnancy is important to prevent mother-to-child transmission of the human immunodeficiency virus (HIV), but their use has been associated with low bone mineral density in adult patients. Currently, there are no data regarding the bone status of HIV-infected women who received ARV during pregnancy. The aim of this study was to evaluate cortical bone status at delivery in a group of HIV-infected women who received ARV during pregnancy and to monitor the changes occurring during the first year postpartum. We studied 33 HIV-infected and 116 HIV-uninfected healthy Caucasian women within 4 days from delivery. Follow-up measurements were performed at 4 and 12 months postpartum in 17 HIV-infected and 55 healthy women. Cortical bone status was evaluated by quantitative ultrasonography at the mid-tibia, and bone measurements were expressed as the speed of sound (SOS). HIV-infected women after delivery had a median SOS of 3,985 (3,567–4,242) m/s, while the median SOS of healthy women was 4,025 (3,643–4,250) m/s. The difference was not significant (t = 0.39, P = 0.69). No significant differences were observed between ARV-exposed and control subjects at 4 and 12 months. Our data suggest that ARV during pregnancy and the first year after delivery does not affect negatively cortical bone status.

This study evaluated the immunogenicity, safety and tolerability of a single 0.5 mL dose of the seasonal virosomal subunit influenza vaccine (Inflexal V, Crucell, Switzerland) in 205 healthy, unprimed children aged at least 6 to

The detection, assessment, understanding and prevention of adverse drug reactions (ADRs) are the primary aims of pharmacovigilance activities. Pediatric patients, especially all newborns and infants, are particularly at risk for experiencing drug-related adverse events.This review briefly analyzes the physiological peculiarities of pharmacodynamic and pharmacokinetic aspects of drugs in newborns, infants and toddlers and children. It also deals with specific pediatric pharmacovigilance aspects, such as the frequent use of unlicensed and/or off-label drugs in neonatal intensive care units in European countries and in Australia. This review reports on European, American and Canadian data about the incidence and type of pediatric ADRs, particularly focusing on neonates, infants and toddlers.The awareness of pediatricians about the importance of reporting ADRs should be stimulated, new reporting systems should be encouraged and pediatric pharmacovigilance activities should be improved, first, by intensifying active post-marketing surveillance methods.

Influenza represents a major sanitary and socio-economic burden and vaccination is universally considered the most effective strategy for preventing the disease and its complications. Traditional influenza vaccines have been on the market since the late 1940s, with million of doses administered annually worldwide, and demonstrated a substantial efficacy and safety.The trivalent inactivated subunit vaccine has been available for more than 25 years and has been studied in healthy children, adults and the elderly and in people affected by underlying chronic medical conditions. We describe vaccine technology focusing on subunit vaccine production procedures and mode of action and provide updated information on efficacy and safety available data.A review of efficacy and safety data in healthy subjects and in high risk populations from major sponsor- and investigator-driven studies.The vaccine showed a good immunogenicity and a favorable safety profile in all target groups. In the panorama of actually available influenza vaccines, trivalent inactivated subunit vaccine represents a well-established tool for preventing flu and the associated complications.

Background Decreased bone mineral density (BMD) has been associated with the use of tenofovir disoproxil fumarate (TDF) in HIV-infected adults. The data in HIV-infected children are conflicting. The aim of this study was to assess the safety of a TDF-containing antiretroviral (ARV) regimen on BMD in paediatric patients. We report the results of a longitudinal 60-month follow-up study. Methods A total of 21 vertically HIV-infected Caucasian youths (10 male and 11 female) on ARV treatment containing lamivudine, efavirenz and TDF were enrolled (age range 4.9–17.9 years at baseline). BMD was measured at the lumbar spine and in the whole skeleton by DXA. Bone-specific alkaline phosphatase (BAP) was measured as a bone formation marker and urinary N-telopeptide of type-I collagen (NTx) was measured as a bone resorption index. Results Baseline mean (±sd) BMD measurements of HIV-infected patients expressed as z-scores were -0.7 (±0.9) for lumbar spine and -0.13 (±1.0) for the whole skeleton. BMD measurements did not change significantly during the 60-month observation period. Both BAP and NTx concentrations were higher than a reference group of controls at baseline and remained unchanged throughout the study. Conclusions Our data indicate that a TDF-containing regimen does not decrease the BMD of HIV-infected youths.

Probiotics are viable microorganisms that can exert potential benefits to human health. Use of probiotics in different human diseases and clinical conditions has gained much attention in the last decades. Several data exist about the potential benefits of probiotics in pediatric age for the management of some clinical conditions, with different and sometimes contrasting results. Currently, strong evidences support the use of probiotics for treatment of acute infectious diarrhoea and prevention of antibiotic-associated diarrhoea: bacteria belonging to the genus of lactobacilli and Saccharomyces boulardii showed the stronger evidences of benefits in different clinical trials and meta-analysis [1,2]. For other pediatric diseases and clinical conditions, evidences of the benefits of a probiotic supplementation are still not so strong. The recommendation to administer a probiotics supplementation in preterm, very low birth weight neonates at risk of developing necrotizing enterocolitis has recently been criticized by a critical review of the literature that conclude that well-designed clinical trials are still needed for suggesting its routinely use in these neonates [3]. Discussion is still ongoing about the benefits of probiotics in prevention or treatment of other pediatric diseases such as respiratory tract infections, urinary tract infections, Helicobacter pylori infection or allergic diseases. Clinical trials and meta-analysis about the use of probiotics in these pediatric clinical conditions have been published and still continued to be published; however, study designs are not always comparable and sometimes inadequate, species of probiotics used in the studies are different and the benefits demonstrated for one microorganism are not generalizable to other bacteria, results of the studies are still often not unequivocal or contrasting so that strong recommendations are still lacking. The use of probiotics has been suggested to be potentially beneficial for the management of gastrointestinal functional disorders, such as irritable bowel syndrome, again, with different results. These clinical conditions are supposed to be the result of a perturbation of the microbiota balance that leads to dysbiosis, responsible for the appearance of the characteristic symptoms. However, pathogenesis of gastrointestinal functional disorders appear to be much more complex and involve the nervous system and its bidirectional interactions with the intestine. Moreover, it has been hypothesized that intestinal microbial composition may itself influence end-points related to mood state, brain function, and mental outlook. A new fascinating perspective in studies about microbiota and probiotics is the characterization of the alterations of intestinal microbiome and their correlation with abnormalities in the bidirectional gut-brain interactions.

Guidelines on immunoprophylaxis for prevention of RSV infection recommend it in preterm babies born before 29 wGA; in babies affected by bronchopulmonary dysplasia or congenital heart defects; and in post-heart transplantation patients. On the contrary, immunoprophylaxis is not recommended in preterm babies born between 29 and 35 wGA. We evaluated the impact of RSV-related healthcare expenditures in infants in the first 3 years of life in Italy, Lombardy Region. In light of the collected data and considering the cost of a complete palivizumab prophylaxis, extending it to babies 29-32 wGA, aged less than 6 months, appears to be a cost-effective strategy.

Objective: To evaluate common carotid artery intima-media thickness (CCIMT) and cardiovascular risk factors in HIV-infected adolescents on combination antiretroviral therapy (cART). Methods: 23 HIV-infected adolescents were matched with 19 healthy subjects by gender, age and body mass index (BMI). CCIMT was measured by Echo-Doppler ultrasound. Bootstrapped multiple linear regression was used to identify potential predictors of CCIMT including HIV status, gender, age, BMI, waist circumference, HDL-cholesterol, LDL- cholesterol, triglycerides, folate, homocysteine and insulin resistance as detected by the homeostasis model assessment, mean blood pressure, and CD36 expression. Results: In the pooled sample, age ranged from 17 to 23 years and BMI between 16.0 and 25.6 kg/m2. Mean (SD) CCIMT was higher in HIV-infected than in healthy subjects [0.5 (0.1) vs 0.4 (0.1) mm, p < 0.001]. Higher values of CCIMT were associated with HIV infection (p < 0.001) and male gender (p < 0.001). CCIMT was also associated with the duration of treatment in subjects with the longest cART exposure, i.e. those exposed to a PI-based and/or NNRTI-based regimen plus a single or double NRTI (p = 0.019). Conclusion: HIV infection and longer duration of cART are associated with higher CCIMT in adolescents and young adults.

The city of Milan is experiencing the great event of EXPO 2015 and heavy construction has been ongoing since 2012 over an area of more than 1 million meters squared in the north-west suburban area of the city. We compared the number of hospital admissions for upper and lower respiratory tract infections (URTI and LRTI) and acute asthma, in infants and children aged between 0 and 13 years from 2011 to 2014 in two Pediatric Departments, one near and one far from the EXPO construction area. Hospital admission frequencies resulted to be similar in the two Pediatric Departments.

Background HPV-associated ano-genital infections represent the most common sexually-transmitted disease in the general population. The incidence of HPV-associated cancers has been increasing in HIV-infected patients. HPV vaccination may be an approach to reduce the risk of HPVassociated cancers in HIV-infected patients and a combined strategy of screening and vaccination may guarantee an adequate prevention of HPV-associated lesions. Immunogenicity of HPV vaccines in HIVinfected patients is still not adequately evaluated. We analyzed immunogenicity of a quadrivalent HPV vaccine in HIV-infected patients without molecular evidence of vaccine-type HPV infection focusing on HPV-specific cell mediated immunity (CMI).