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Assessment of the advantage of the serum S100B protein biomonitoring in the management of paediatric mild traumatic brain injury-PROS100B: protocol of a multicentre unblinded stepped wedge cluster randomised trial.
Bouvier, D, Balayssac, D, Durif, J, Mourgues, C, Sarret, C, Pereira, B, Sapin, V
BMJ open. 2019;(5):e027365
Abstract
INTRODUCTION S100B serum analysis in clinical routine could reduce the number of cranial CT (CCT) scans performed on children with mild traumatic brain injury (mTBI). Sampling should take place within 3 hours of trauma and cut-off levels should be based on paediatric reference ranges. The aim of this study is to evaluate the utility of measuring serum S100B in the management of paediatric mTBI by demonstrating a decrease in the number of CCT scans prescribed in an S100B biomonitoring group compared with a 'conventional management' control group, with the assumption of a 30% relative decrease of the number of CCT scans between the two groups. METHODS AND ANALYSIS The protocol is a randomised, multicentre, unblinded, prospective, interventional study (nine centres) using a stepped wedge cluster design, comparing two groups (S100B biomonitoring and control). Children in the control group will have CCT scans or be hospitalised according to the current recommendations of the French Society of Paediatrics (SFP). In the S100B biomonitoring group, blood sampling to determine serum S100B protein levels will take place within 3 hours after mTBI and subsequent management will depend on the assay. If S100B is in the normal range according to age, the children will be discharged from the emergency department after 6 hours' observation. If the result is abnormal, CCT scans or hospitalisation will be prescribed in accordance with current SFP recommendations. The primary outcome measure will be the proportion of CCT scans performed (absence/presence of CCT scan for each patient) in the 48 hours following mTBI. ETHICS AND DISSEMINATION The protocol presented (Version 5, 03 November 2017) has been approved by the ethics committee Comité de Protection des Personnes sud-est 6 (first approval 08 June 2016, IRB: 00008526). Participation in the study is voluntary and anonymous. The study findings will be disseminated in international peer-reviewed journals and presented at relevant conferences. TRIAL REGISTRATION NUMBER NCT02819778.
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Practice-tailored facilitation to improve pediatric preventive care delivery: a randomized trial.
Meropol, SB, Schiltz, NK, Sattar, A, Stange, KC, Nevar, AH, Davey, C, Ferretti, GA, Howell, DE, Strosaker, R, Vavrek, P, et al
Pediatrics. 2014;(6):e1664-75
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OBJECTIVE Evolving primary care models require methods to help practices achieve quality standards. This study assessed the effectiveness of a Practice-Tailored Facilitation Intervention for improving delivery of 3 pediatric preventive services. METHODS In this cluster-randomized trial, a practice facilitator implemented practice-tailored rapid-cycle feedback/change strategies for improving obesity screening/counseling, lead screening, and dental fluoride varnish application. Thirty practices were randomized to Early or Late Intervention, and outcomes assessed for 16 419 well-child visits. A multidisciplinary team characterized facilitation processes by using comparative case study methods. RESULTS Baseline performance was as follows: for Obesity: 3.5% successful performance in Early and 6.3% in Late practices, P = .74; Lead: 62.2% and 77.8% success, respectively, P = .11; and Fluoride: <0.1% success for all practices. Four months after randomization, performance rose in Early practices, to 82.8% for Obesity, 86.3% for Lead, and 89.1% for Fluoride, all P < .001 for improvement compared with Late practices' control time. During the full 6-month intervention, care improved versus baseline in all practices, for Obesity for Early practices to 86.5%, and for Late practices 88.9%; for Lead for Early practices to 87.5% and Late practices 94.5%; and for Fluoride, for Early practices to 78.9% and Late practices 81.9%, all P < .001 compared with baseline. Improvements were sustained 2 months after intervention. Successful facilitation involved multidisciplinary support, rapid-cycle problem solving feedback, and ongoing relationship-building, allowing individualizing facilitation approach and intensity based on 3 levels of practice need. CONCLUSIONS Practice-tailored Facilitation Intervention can lead to substantial, simultaneous, and sustained improvements in 3 domains, and holds promise as a broad-based method to advance pediatric preventive care.
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"Greenlight study": a controlled trial of low-literacy, early childhood obesity prevention.
Sanders, LM, Perrin, EM, Yin, HS, Bronaugh, A, Rothman, RL, ,
Pediatrics. 2014;(6):e1724-37
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Children who become overweight by age 2 years have significantly greater risks of long-term health problems, and children in low-income communities, where rates of low adult literacy are highest, are at increased risk of developing obesity. The objective of the Greenlight Intervention Study is to assess the effectiveness of a low-literacy, primary-care intervention on the reduction of early childhood obesity. At 4 primary-care pediatric residency training sites across the US, 865 infant-parent dyads were enrolled at the 2-month well-child checkup and are being followed through the 24-month well-child checkup. Two sites were randomly assigned to the intervention, and the other sites were assigned to an attention-control arm, implementing the American Academy of Pediatrics' The Injury Prevention Program. The intervention consists of an interactive educational toolkit, including low-literacy materials designed for use during well-child visits, and a clinician-centered curriculum for providing low-literacy guidance on obesity prevention. The study is powered to detect a 10% difference in the number of children overweight (BMI > 85%) at 24 months. Other outcome measures include observed physician-parent communication, as well as parent-reported information on child dietary intake, physical activity, and injury-prevention behaviors. The study is designed to inform evidence-based standards for early childhood obesity prevention, and more generally to inform optimal approaches for low-literacy messages and health literacy training in primary preventive care. This article describes the conceptual model, study design, intervention content, and baseline characteristics of the study population.
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Efficacy of U.S. paediatric obesity primary care guidelines: two randomized trials.
Raynor, HA, Osterholt, KM, Hart, CN, Jelalian, E, Vivier, P, Wing, RR
Pediatric obesity. 2012;(1):28-38
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OBJECTIVE The objective of this study was to examine the efficacy of U.S. primary care paediatric obesity treatment recommendations, within two randomized trials. METHODS Between November 2005 to September 2007, 182 families (children aged 4-9 years, body mass index [BMI] ≥85th percentile) were recruited for two separate trials and randomized within trial to a 6-month intervention. Each trial had one intervention that increased child growth-monitoring frequency and feedback to families (GROWTH MONITORING). Each trial also had two interventions, combining GROWTH MONITORING with an eight-session, behavioural, parent-only intervention targeting two energy-balance behaviours (Trial 1: reducing snack foods and sugar-sweetened beverages [DECREASE], and increasing fruits, vegetables and low-fat dairy [INCREASE]; Trial 2: decreasing sugar-sweetened beverages and increasing physical activity [TRADITIONAL] and increasing low-fat milk consumption and reducing television watching [SUBSTITUTES]). Child standardized BMI (ZBMI) and energy intake were assessed at 0, 6 and 12 months. RESULTS In both trials, main effects of time were found for ZBMI, which decreased at 6 and 12 months (P < 0.01). In Trial 1, ZBMI reduced from 0 to 6 months, which was maintained from 6 to 12 months (ΔZBMI 0 to 12 months = -0.12 ± 0.22). In Trial 2, ZBMI reduced from 0 to 6 and from 6 to 12 months (ΔZBMI 0-12 months = -0.16 ± 0.31). For energy intake, main effects of time were found in both trials and intake reduced from 0 to 6 months (P < 0.05), with Trial 1 reducing intake from 0 to 12 months (P < 0.05). CONCLUSIONS All interventions improved weight status. Future research should examine effectiveness and translatability of these approaches into primary care settings.
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The applicability and efficacy of guidelines for the management of acute gastroenteritis in outpatient children: a field-randomized trial on primary care pediatricians.
Albano, F, Lo Vecchio, A, Guarino, A
The Journal of pediatrics. 2010;(2):226-30
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OBJECTIVE To evaluate the applicability and efficacy of guidelines for the management of acute gastroenteritis (AGE) as used by pediatricians. STUDY DESIGN This was a national, open, randomized, controlled intervention trial. The intervention consisted of a 2-hour course based on the guidelines for management of AGE. Seventy-five randomly selected primary care pediatricians underwent training in AGE management (group A), and 75 pediatricians who were not specifically trained served as controls (group B). Each pediatrician enrolled 10 children age 1-36 months with acute-onset diarrhea. Outcome measures were guidelines applicability, duration of diarrhea, and difference in body weight between the first visit and 5-7 days later. RESULTS The baseline features of the children were similar in groups A (n = 617) and B (n = 692). A total of 404 of the 617 children in group A (65.5%) were fully treated according to the guidelines, compared with 20 of the 692 children in group B (3%). Most violations involved administration of unnecessary drugs or diets. The duration of diarrhea was shorter in group A (intention-to-treat: 83.3 vs 90.9 hours; P < .001). Weight gain was marginally, but statistically significantly, higher in the children treated according to the guidelines (per-protocol analysis: +16.5 gr vs -13.5 gr; P < .05). CONCLUSIONS Guidelines for AGE have good applicability and excellent efficacy. Adjunctive medical interventions are associated with a longer duration of diarrhea.
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"Mi voglio bene": a pediatrician-based randomized controlled trial for the prevention of obesity in Italian preschool children.
Brambilla, P, Bedogni, G, Buongiovanni, C, Brusoni, G, Di Mauro, G, Di Pietro, M, Giussani, M, Gnecchi, M, Iughetti, L, Manzoni, P, et al
Italian journal of pediatrics. 2010;:55
Abstract
BACKGROUND The first years of life are crucial to start preventive interventions that can have an impact on lifestyle and later overweight and obesity. Under the Italian National Health System (INHS), children are cared for by family pediatricians who perform health balances at regular intervals. The Italian Society of Preventive and Social Pediatrics (SIPPS) has designed a randomized controlled trial (RCT) to evaluate the effectiveness of family pediatricians for the prevention of childhood obesity in preschool children. We report the rationale and protocol of such trial, named the "Mi voglio bene" ("I love myself") study. METHODS "Mi voglio bene" is a parallel-arm RCT. Family pediatricians willing to participate to the trial will be randomly assigned to a control group and to an experimental group. The control group will provide the usual standard of care while the experimental group will implement 10 preventive actions (promotion of breastfeeding, avoidance of solid foods, control of protein intake, avoidance of sugar-sweetened beverages, avoidance of bottle, active means of transportation, identification of early adiposity rebound, limitation of television viewing, promotion of movement, and teaching portion size) at 10 time points during a 6-yr follow-up. The main outcome measures is the prevalence of overweight and obesity at 6 years of age. The experimental intervention is expected to reduce the prevalence of overweight and obesity from 25% to 20% and the study requires a total of 3610 children. Each pediatrician will enroll 30 consecutive newborns into the study so that a total of 120 pediatricians will participate to the study. DISCUSSION "Mi voglio bene" is expected to provide important information for the INHS and possibly other institutional child care settings about the effectiveness of a pediatrician-based approach to the prevention of childhood obesity. We published this study protocol with the aim of opening a discussion with all people interested in fighting childhood obesity and to receive useful criticisms.
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A randomized, controlled trial of sucrose analgesia in infants younger than 90 days of age who require bladder catheterization in the pediatric emergency department.
Rogers, AJ, Greenwald, MH, Deguzman, MA, Kelley, ME, Simon, HK
Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2006;(6):617-22
Abstract
OBJECTIVES To determine whether an oral sucrose solution improves pain response for infants undergoing bladder catheterization in an emergency department (ED) population. METHODS A randomized, double-blinded study comparing the analgesic effects of a sucrose solution to placebo for infants < or = 90 days of age and requiring bladder catheterization. Infants with prior bladder catheterization, previous painful procedures that day, or neurological or genital abnormalities were excluded. Infants were assigned baseline pain scores and then given 2 mL of sucrose or water 2 minutes before catheterization. Trained pediatric ED nurses rated the infants for pain, presence of cry, and time to return to baseline. RESULTS Eighty-three patients were enrolled; 40 were randomized to sucrose, and 40, to placebo. Baseline pain scores were similar within each age group. Overall, sucrose did not produce a significant analgesic effect. In subgroup analysis, infants 1-30 days of age receiving sucrose showed a smaller change in pain scores (2.9 vs. 5.3, p = 0.035), were less likely to cry with catheterization (29% vs. 72%, p = 0.008), and returned to baseline more rapidly after catheter removal (10 seconds vs. 37 seconds, p = 0.04) compared with infants who received placebo. Infants older than 30 days of age who received sucrose did not show statistically significant differences in pain scores, crying, or time to return to baseline behavior. CONCLUSIONS There was no overall treatment effect when using an oral sucrose solution before bladder catheterization in infants younger than 90 days of age. However, infants younger than or equal to 30 days of age who received sucrose had smaller increases in pain scores, less crying, and returned to baseline more rapidly than infants receiving placebo. Older infants did not show an improved pain response with oral sucrose.
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Gastric residual volumes in critically ill paediatric patients: a comparison of feeding regimens.
Horn, D, Chaboyer, W, Schluter, PJ
Australian critical care : official journal of the Confederation of Australian Critical Care Nurses. 2004;(3):98-100, 102-3
Abstract
This study examined the effect of gastric feeding regimens, either continuous or intermittent, on fourth hourly gastric residual volumes (GRV) in a group of critically ill paediatric patients where delayed gastric emptying is defined as a GRV greater than 5ml/kg. A randomised controlled trial was conducted in a tertiary paediatric intensive care unit (PICU), with 45 participants being randomly assigned to either the continuous (n=22) or intermittent (n=23) gastric feeding groups. Participants remained in the assigned group for the duration of the study and, fourth hourly, GRV were assessed to monitor the incidence of delayed gastric emptying. Both groups were similar in age, weight, gender, diagnosis, paediatric index mortality (PIM) score, and usage of pharmacological agents known to affect the gastrointestinal tract. No differences emerged in study duration or the volume of administered enteral formula (ml/kg/day). The intermittent feeding group commenced enteral feeding earlier in the PICU admission (13.0 hours versus 18.5 hrs, p=0.05). Repeated measures analysis revealed no overall difference in median GRV/kg values between treatment groups over the 72 hour study period. Additionally, the incidence of fourth hourly GRV, greater than 5ml/kg, was not different between the continuous and intermittent feeding groups. The provision of enteral nutrition via the gastric route is a common treatment in the PICU, and GRV are frequently used as a measure of gastric tolerance. The result of this analysis provides some support for the theoretical definition of delayed gastric emptying being >5ml/kg. However, further work is required to confirm this finding and to determine its relevance when providing enteral nutrition to the critically ill paediatric patient.