0
selected
-
1.
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.
-
2.
Survey on treatments for primary headaches in 13 specialized juvenile Headache Centers: The first multicenter Italian study.
Toldo, I, Rattin, M, Perissinotto, E, De Carlo, D, Bolzonella, B, Nosadini, M, Rossi, LN, Vecchio, A, Simonati, A, Carotenuto, M, et al
European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society. 2017;(3):507-521
Abstract
AIM: The purpose of this retrospective multicenter study was to evaluate the use and the self-perceived efficacy and tolerability of pharmacological and non-pharmacological treatments in children and adolescents with primary headaches. METHODS Study of a cohort of children and adolescents diagnosed with primary headache, consecutively referred to 13 juvenile Italian Headache Centers. An ad hoc questionnaire was used for clinical data collection. RESULTS Among 706 patients with primary headaches included in the study, 637 cases with a single type of headache (migraine 76% - with and without aura in 10% and 67% respectively; tension-type headache 24%) were selected (mean age at clinical interview: 12 years). Acetaminophen and non-steroidal anti-inflammatory drugs (in particular ibuprofen) were commonly used to treat attacks, by 76% and 46% of cases respectively. Triptans were used overall by 6% of migraineurs and by 13% of adolescents with migraine, with better efficacy than acetaminophen and non-steroidal anti-inflammatory drugs. Preventive drugs were used by 19% of migraineurs and by 3% of subjects with tension-type headache. In migraineurs, flunarizine was the most frequently used drug (18%), followed by antiepileptic drugs (7%) and pizotifen (6%), while cyproheptadine, propanolol and amitriptyline were rarely used. Pizotifen showed the best perceived efficacy and tolerability. Melatonin and nutraceuticals were used by 10% and 32% of subjects, respectively, both for migraine and tension-type headache, with good results in terms of perceived efficacy and tolerability. Non-pharmacological preventive treatments (i.e. relaxation techniques, biofeedback, cognitive-behavioral therapy, acupuncture) were used only by 10% of cases (migraine 9%, tension-type headache 15%). DISCUSSION Non-steroidal anti-inflammatory drugs, especially ibuprofen, should be preferred to acetaminophen for acute attacks of migraine or tension-type headache, because they were usually more effective and well tolerated. Triptans could be used more frequently as first or almost second choice for treating migraine attack in adolescents. Non-pharmacological preventive treatments are recommended by some pediatric guidelines as first-line interventions for primary headaches and their use should be implemented in clinical practice. Prospective multicenter studies based on larger series are warranted to better understand the best treatment strategies for young people with primary headaches.
-
3.
"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
-
-
Free full text
-
Abstract
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.
-
4.
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
-
-
Free full text
-
Abstract
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.
-
5.
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
Abstract
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.