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The article highlights views from several parents on the principles for cluster randomised trials that involve infants and neonates. Topics include the role of the European Foundation for the Care of Newborn Infants in bringing together healthcare experts and scientists and parents with shared goals to boost the long-term health of newborn and pre-term infants and the importance to provide infants with best possible care, treatment and prevention.

Aim: To measure the relationship of resting energy expenditure (REE) and body composition, and to compare REE data calculated from anthropometric parameters using published equations with measurements obtained by indirect calorimetry (IC) in a population of obese paediatric patients.Methods: The study included 82 healthy obese paediatric subjects (49 boys, 33 girls; body mass index 29.6 +/- 5.0 kg/m , age 1 1.4 +/- 2.6 y, weight 72.4 +/- 20.9 kg, height 155 +/- 14 cm). REE was measured by IC, body composition was determined by dual energy X-ray absorptiometry (DXA). Bootstrap analysis was performed to validate the step-down linear regression analysis results.Results: Lean body mass (LBM) and weight were identified as the most significant determinants of REE. LBM was the best single predictor (r = 0.78; p < 0.001) for REE. Regression equations are given in the text. Prediction of REE on the basis of published anthropometric formulas was strongly dependent from the equation used. Some equations tend to underestimate REE in the population studied with a considerable systematic error.Conclusion: In the present paper we show that (1) the published equations to predict REE in obese subjects yield scattered data and some are even biased by a systematic error, and that (2) the inclusion of DXA-derived LBM improves accuracy and precision of predicted REE in boys and girls aged from 4 to 10 y and in boys from 11 to 15 y. [ABSTRACT FROM AUTHOR]

Unlabelled: Constipation, faecal incontinence, soiling and difficult toilet training remain significant problems in children with Hirschsprung's disease after corrective surgery. Chronic defecation problems can have various negative implications. At the University Medical Centre Nijmegen, a multidisciplinary behavioural treatment was developed to treat defecation problems. In this paper, a prospective controlled study is presented concerning the effect of this treatment upon children suffering from chronic defecation problems following corrective surgery for Hirschsprung's disease. The effect of treatment was studied in 27 children (21M, 6F, mean age 5.2y, range 2-11 y). Fourteen children were allocated to the experimental treatment group. The 13 children allocated to the waiting-list control group were also treated following a waiting period of 6 mo. On all outcome variables, children in the experimental treatment group had significantly better results after treatment than children in the waiting-list control group after the waiting period. No effect of age upon treatment was found. The effect of treatment remained significant on all outcome variables at a mean follow-up of 7 mo after the end of treatment.Conclusion: Multidisciplinary behavioural treatment is successful in decreasing chronic defecation problems in children with Hirschsprung's disease. [ABSTRACT FROM AUTHOR]

Aim: Pulmonary hypertension (PH) frequently complicates neonatal hypoxaemic respiratory failure, but is inconsistently defined. We aimed to describe the variation among randomised controlled trials (RCTs) of inhaled nitric oxide (iNO), in relation to the definition of PH and/or hypoxaemic respiratory failure used to select patients for trial inclusion.Methods: PubMed, Cochrane Library and ClinicalTrials.gov were systematically searched for RCTs of iNO in neonates. Included studies were assessed for clinical and/or echocardiography criteria used to define PH/hypoxaemic respiratory failure.Results: Thirty-two trials were included in this review, of which 23 enrolled infants ≥34 weeks' gestation. Echocardiographic diagnosis was used in 21 studies, but there was considerable variation in the echocardiographic parameters used to diagnose PH. The most commonly used indices included markers of tricuspid regurgitation and extrapulmonary shunt.Conclusion: There is wide variation in the definition of PH used to select infants for inclusion into RCTs of iNO therapy in neonates. We recommend that an international consensus be reached on which parameters should be used and the thresholds defining severity of disease. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to evaluate the HemoCue WBC DIFF system for point of care testing of fingerstick samples from paediatric patients.Methods: We analysed 158 white blood cell counts on both the point of care HemoCue WBC DIFF instrument and the Cell Dyn Sapphire cell counter used by our central laboratory and compared the results. The measurements were performed using fingerstick samples drawn by nurses working in paediatric emergency and paediatric oncology units.Results: There was good agreement between the two instruments for white blood cell and neutrophil counts. The correlation was weaker for lymphocytes, and the correlations were poor for monocytes and eosinophils. The HemoCue WBC DIFF flagged 56 of the 148 capillary drawn samples as abnormal, but none of the 10 venously collected samples. Only two of the flagged samples differed significantly between the instruments, with regard to the cell counts.Conclusion: The correlations between the white blood cell counts and neutrophil counts in this real-life study were good enough to diagnose children in emergency department and oncology unit settings. However, the high number of pathological flags from fingerstick samples, which made reruns necessary, limited the usefulness of the instrument. [ABSTRACT FROM AUTHOR]

Background: Major changes in drug clearance and metabolism are observed during infancy, in part based on ontogenic regulation of various metabolic pathways. Since paracetamol provides a good substrate to study UGT (1A6) activity, urinary metabolites of propacetamol were determined in neonates in whom propacetamol was repeatedly administered.Methods: Paracetamol glucuronide (APAP-G), paracetamol sulphate (APAP-S) and free paracetamol were determined in urine samples of neonates during repeated administration of propacetamol. Spearman rank and linear multiple regression (MedCalc, Mariakerke, Belgium) were used to study the effect of postnatal age, of postconceptional age and of repeated administration on the relative contribution of APAP-G to overall urine paracetamol (APAP-G+APAP-S+free paracetamol) elimination (G/T ratio).Results: 147 samples were collected in 23 neonates. Molar median G/T ratio was 14% (range 1-53). Besides increasing G/T ratio with increasing postnatal (p<0.0001) and postconceptional age (p<0.01), repeated administration (p<0.01) also correlated with an increasing G/T ratio, and repeated administration remained significant (p<0.01) after correction of postnatal and postconceptional age in a multiple regression model.Conclusion: Major variability in the ontogeny of UGT activity to overall elimination of paracetamol was documented in neonates. Besides postnatal and postconceptional age, a significant effect of repeated administration on UGT activity was documented. [ABSTRACT FROM AUTHOR]

Aim: To assess whether children with Noonan syndrome on long-term growth hormone (GH) therapy improve their final height to near mid-parental height.Methods: Twenty-five prepubertal children (13 girls) with Noonan syndrome (NS) were studied. A single clinician made the diagnosis based on clinical criteria. GH treatment started at an age ranging from 3.1 to 13.8 y and was continued for at least 2 y. Improvement or "gain" in final height (FH) was defined as either the difference between adult height SD scores (SDS) and pre-treatment height SDS (the childhood component of the Swedish reference) or height SDS compared to the Noonan reference.Results: Ten children received a GH dose of 33 microg/kg/d (mean age at start 7.7+/-2.1 y, mean age at stop 17.6+/-1.7 y) and 15 received a dose of 66 microg/kg/d (mean age at start 8.6+/-3.3 y, mean age at stop 18.4+/-2.1 y). Eighteen out of 25 patients reached FH. A substantial improvement in FH of 1.7 SDS, equivalent to 10.4 cm compared to pre-treatment height, was observed. No significant difference was seen between the two GH doses. Females gained a mean height of 9.8 cm and males 1-13 cm (FH 174.5+/-7.8 cm vs mean adult height of 162.5+/-5.4 cm for males with NS) at final height. Moreover, 60% reached a mid-parental height of+/-1 SD.Conclusion: GH treatment improves final height in patients with Noonan syndrome, with a mean gain of 1.7 SDS. The prepubertal height gain is maintained to final height and the children achieve a height close to their mid-parental height. [ABSTRACT FROM AUTHOR]

Aim: To test whether a well-designed educational package on the implementation of kangaroo mother care (KMC) used on its own can be as effective in implementing KMC in a healthcare facility as the combination of a visiting facilitator used in conjunction with the package.Setting: Thirty-four hospitals in KwaZulu-Natal Province, South Africa.Method: The hospitals were paired with respect to their geographical location and annual number of births at the facility. One hospital in each pair was randomly allocated to receive either the implementation package alone (group A) or the implementation package and visits from a facilitator (group B). Hospitals in group B received three facilitation visits. All hospitals were evaluated by a site visit 8 mo after launching the process and were scored by means of a progress-monitoring tool.Outcomes: Successful implementation was regarded as demonstrating evidence of practice (score>10) during the site visit.Results: Group B scored significantly better than group A (p<0.05). All 17 hospitals in group B demonstrated evidence of practice, with the median score of the group being 15.44 (range 10.29-22.94). Twelve of the hospitals in group A demonstrated evidence of practice and the median score was 11.33 (range 1.08-21.13).Conclusion: Successful implementation was achieved in most of the hospitals irrespective of the strategy used. However, facilitation with an implementation package was clearly superior to using a package alone. Some sites do not need facilitation for successful implementation. [ABSTRACT FROM AUTHOR]

Aims: To study relations between test performance, academic self-esteem, self-reported stress and saliva cortisol levels in students exposed to test demands at school.Methods: 46 randomly selected 6th and 9th graders voluntarily participated in an experimental school test concerning reading and mathematics skills. Cortisol saliva samples were collected at awakening, 30 min later, before test and after test. Perceived stress was registered with a visual analogue scale (VAS). A standardized self-rating questionnaire for measuring self-esteem was administered together with questions about school stress and psychological reactions when exposed to stress during a test.Results: Experienced stress during the school test was correlated to low test performance and to low self-rated evaluation of self-esteem as well as to an increase of saliva cortisol levels during the test. There were also correlations between certain psychological reactions to demands and different cortisol measures. Children who reported that they applied the procedure "I say to myself: I can solve this task" in a school test situation had a lower morning increase of saliva cortisol. Reported use of the procedure "I get worried and will have problems solving other tasks too"--when referring to a school test situation--was correlated to an increase in cortisol levels during the test situation.Conclusion: Test performance, academic self-esteem, perceived stress and reactions of the hypothalamus-pituitary-adrenal axis (HPA axis) are highly intertwined. Furthermore, certain school stress psychological reactions to performance demands seem to be related to different cortisol reactions. [ABSTRACT FROM AUTHOR]

Aims: To evaluate the effect of the implementation of an asthma clinical pathway on asthma in children in general practice.Methods: A randomized, controlled trial involving 270 general practitioners. One group of general practitioners implemented the asthma clinical pathway for children (intervention group) and the control group continued with their usual asthma medical care management. The main outcome measures were admissions to hospital for asthma and attendance at the Children's Emergency Department. Compliance with the guidelines was assessed by examining asthma drug prescriptions.Results: Admissions to hospital for asthma dropped 40% in the intervention group, by 33% in the control group and by 22% in general practitioners not participating in the trial. The differences between the intervention and control and between the intervention and non-participating general practitioners were not statistically significant. The decrease in attendance at the Children's Emergency Department decreased by 25%, 30% and 19%, respectively, but this was not statistically significant. There was a significant decrease in prescriptions for oral relievers, dry powder relievers in the under 6s, mast cell stabilizers and methylxanthines in both control and intervention groups. However, only for oral relievers was there a significant difference between the intervention group and control, with the decrease larger in the intervention group (p < 0.001).Conclusions: Admissions to hospital for asthma decreased, as did attendance at the Children's Emergency Department. Prescriptions for asthma medication changed in the direction anticipated with compliance with the asthma clinical pathway. However, we found no evidence within the study that implementation of the asthma clinical pathway by general practitioners resulted in lower morbidity than those general practitioners who did not implement the pathway. Possible explanations are that these general practitioners were already providing care according to the recommendations of the pathway, or that there was contamination of the control group by the intervention, or that the guidelines, although based on currently accepted recommendations, are ineffective. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effects of gender, apolipoprotein E phenotype and cholesterol absorption and synthesis (estimated as serum plant sterol and cholesterol precursor sterol concentrations) on the cholesterol-lowering effect of plant stanol esters in children.Methods: Eighty-one healthy, normocholesterolaemic 6-y-old children (45 boys) were recruited from the Special Turku Coronary Risk Factor Intervention Project (STRIP), a randomized prospective trial aiming at atherosclerosis prevention in childhood. This placebo-controlled, double-blind, cross-over study comprised two 3-mo study periods and a 6-wk wash-out period. During the study periods, 20 g of the children's daily dietary fat intake was replaced with plant stanol ester margarine or control margarine.Results: In boys, plant stanol esters reduced serum total and low-density lipoprotein cholesterol concentrations by 6% (0.09 to 0.42 mmol/L) and 9% (0.09 to 0.36 mmol/L), respectively (p < 0.01 for both). In girls, the decreases in concentrations were 4% (0.03 to 0.38 mmol/L) and 6% (0.02 to 0.32 mmol/l) (p < 0.05 for both). The response rate did not differ between the genders. Serum total and low-density lipoprotein cholesterol concentrations decreased by 6% and 8% (p < 0.01 for both), respectively, in both children with the apolipoprotein E 3/4 or 4/4 (apoE4+) phenotype and the apolipoprotein E 2/3 or 3/3 (apoE4-) phenotype. Cholesterol absorption decreased both in the apoE4+ children and in the apoE4- children, but cholesterol synthesis consistently increased in the apoE4+ children only.Conclusion: Plant stanol esters reduce serum cholesterol concentration in healthy children irrespective of their gender or apoE4 phenotype. [ABSTRACT FROM AUTHOR]

Unlabelled: A randomized, controlled, prospective study of 80 preterm infants of birthweight less than 1750 g requiring ventilatory support was performed. While ventilatory support was required group TF (39 infants) received trophic feeding (0.5-1 ml h(-1)) along with parenteral nutrition, whereas group C (41 infants) received parenteral nutrition alone. When ventilatory support was no longer required milk feeds were started in group C and then increased in both groups until full milk feeds were established. The ratio of lactase to sucrase activity (L:S ratio) was measured in aspirated proximal intestinal fluid on 3 occasions: immediately after ventilatory support was withdrawn (T0), 7 days later (T7) and 14 days later (T14). On the same 3 occasions faecal chymotrypsin activity was measured. The mean difference (95% confidence interval) L:S ratio was significantly higher in group TF at both T0 and T14, 1.8 (0.03, 3.57) and 0.78 (0.2, 1.35) U l(-1), respectively. There was no significant difference in faecal chymotrypsin concentration.Conclusion: Trophic feeding alters relative intestinal disaccharidase activity, probably by inducing lactase production, but has no effect on pancreatic chymotrypsin activity. [ABSTRACT FROM AUTHOR]

Unlabelled: Immunological approaches have been considered as an alternative therapeutic option for the treatment of enteric infections over the past few years. Hyperimmune bovine colostrum (HBC) is a potentially innovative immunological option in the management of shigellosis together with traditional antibiotic therapy. Children aged 1-12 y with a history of bloody mucoid diarrhoea of less than 5 d duration were enrolled after their stool specimen was found to be positive for Shigella dysenteriae type I antigen by a rapid diagnostic fluorescent antibody staining test. They were randomized to receive either HBC containing very high titres of antibody against S. dysenteriae type I antigen or bovine colostrum (BC) without any antibody. The study group received 100 ml of HBC three times a day orally for 3 d and control group received BC. Children also received pivmecillinam in a dose of 50 mg kg(-1) d(-1) in four divided doses orally for 5 d. Admission characteristics of the 34 children in the HBC group and 35 in the BC group were comparable. No significant differences were observed in duration of diarrhoea, fever, anorexia, abdominal pain, tenesmus, stool frequency or visible blood in the stool between the groups. Two (6%) children in the study and five (14%) in the control group remained stool culture positive for S. dysenteriae type 1, even after 5 d of sensitive antimicrobial therapy.Conclusion: The results indicate that HBC as an adjuvant is unable to show any beneficial effect in reducing the stool frequency, duration or severity of childhood shigellosis due to S. dysenteriae type I infection. [ABSTRACT FROM AUTHOR]

We investigated colonization with Ureaplasma urealyticum (Uu) in infants <30 weeks gestation and assessed the relationship to other risk factors influencing respiratory morbidity, plus the effect of treatment with erythromycin. Ventilated preterm infants [n = 155; median GA 26 (23-29) weeks] were cultured for Uu in endotracheal aspirate and nasopharynx. Colonized infants were randomly assigned to treatment with erythromycin 40 mg/kg/d, intravenously or orally. The rate of colonization was 29/155 (19%) and the Uu-colonized infants had lower mean gestational ages than the culture-negative infants (25 vs 26 weeks). For the colonized infants PROM (48% vs 12%), chorioamnionitis in the mother (46% vs 17%) and vaginal delivery (71% vs 29%) were more common. More colonized infants needed supplemental oxygen at 36 weeks' postconceptual age (p < 0.05). Erythromycin treatment was effective in reducing colonization with negative control cultures in 12/14 (86%) of treated infants. No significant differences were found between the colonized treated infants (n = 14) and those not treated (n = 14) in time with supplemental oxygen. Oxygen requirement at 36 weeks was related to lower gestational age, late appearance of PDA, late onset sepsis and signs of chorioamnionitis in the mother. We conclude that the Uu colonization is related to increasing immaturity, the presence of prolonged rupture of membranes, signs of chorioamnionitis and vaginal delivery. Treatment with erythromycin reduced colonization but did not significantly alter length of time with supplemental oxygen. [ABSTRACT FROM AUTHOR]