Impact of an early educational protocol on the oral language of children born preterm exhibiting phonological fragility: a multicenter randomized clinical trial.

Unlabelled: We conducted a six-center, prospective, randomized, open-label trial to assess whether an early standardized educational protocol provided from 42 to 48 months of age improved the progression of oral language and phonological development in children born preterm. A total of 552 children with phonological fragility were included in this study. The children were randomized to receive the educational protocol (guided arm,  = 87) or not (non-guided arm,  = 78).

Respiratory outcomes and survival after unplanned extubation in the NICU: a prospective cohort study from the SEPREVEN trial.

Objective: To compare reintubation rates after planned extubation and unplanned extubation (UE) in patients in neonatal intensive care units (NICUs), to analyse risk factors for reintubation after UE and to compare outcomes in patients with and without UE.

Design: Prospective, observational study nested in a randomised controlled trial (SEPREVEN/Study on Epidemiology and PRevention of adverse EVEnts in Neonates). Outcomes were expected to be independent of the intervention tested.

Effect of gestational age on cerebral lesions in neonatal encephalopathy.

Objective: To determine the risk on brain lesions according to gestational age (GA) in neonates with neonatal encephalopathy.

Design: Secondary analysis of the prospective national French population-based cohort, Long-Term Outcome of NeonataL EncePhALopathy.

Setting: French neonatal intensive care units.

Variations in neonatal mortality of preterm infants with intraparenchymal haemorrhage in Europe: the EPICE cohort.

Objective: The aim of this study was to investigate variations in mortality before neonatal intensive care unit (NICU) discharge of infants born preterm with intraparenchymal haemorrhage (IPH) in Europe with a special interest for withdrawing life-sustaining therapy (WLST).

Design: Secondary analysis of the Effective Perinatal Intensive Care in Europe (EPICE) cohort, 2011-2012.

Setting: Nineteen regions in 11 European countries.

Management of respiratory distress in moderate and late preterm infants: clinical trajectories in the Neobs study.

Unlabelled: Management of respiratory distress (RD) in the extremely preterm newborn meets recommendations. Few data are available concerning the management and the clinical course of moderate and late preterms with RD. Clinical course and management among moderate (30-33 weeks (wks) of gestation) and late preterms (34-36 wks) were assessed in the Neobs study, a French neonatal observational cohort study (2018) of preterms with RD in the first 24 h of life.

Early factors associated with continuous positive airway pressure failure in moderate and late preterm infants.

To determine the early factors associated with continuous positive airway pressure (CPAP) failure in moderate-to-late preterm infants (32 + 0/7 to 36 + 6/7 weeks' gestation) from the NEOBS cohort study. The NEOBS study was a multi-center, prospective, observational study in 46 neonatal intensive care units in France, which included preterm and late preterm infants with early neonatal respiratory distress. This analysis included a subset of the NEOBS population who had respiratory distress and required ventilatory support with CPAP within the first 24 h of life.

Glycemia and Neonatal Encephalopathy: Outcomes in the LyTONEPAL (Long-Term Outcome of Neonatal Hypoxic EncePhALopathy in the Era of Neuroprotective Treatment With Hypothermia) Cohort.

Objectives: To assess in newborns with neonatal encephalopathy (NE), presumptively related to a peripartum hypoxic-ischemic event, the frequency of dysglycemia and its association with neonatal adverse outcomes.

Study Design: We conducted a secondary analysis of LyTONEPAL (Long-Term Outcome of Neonatal hypoxic EncePhALopathy in the era of neuroprotective treatment with hypothermia), a population-based cohort study including 545 patients with moderate-to-severe NE. Newborns were categorized by the glycemia values assessed by routine clinical care during the first 3 days of life: normoglycemic (all glycemia measurements ranged from 2.

Risk factors for unfavorable outcome at discharge of newborns with hypoxic-ischemic encephalopathy in the era of hypothermia.

Objective: To re-visit short-term outcomes and associated risk factors of newborns with hypoxic-ischemic encephalopathy (HIE) in an era where hypothermia treatment (HT) is widespread.

Methods: This is a prospective population-based cohort in French neonatal intensive care units (NICU). Neonates born at or after 34 weeks of gestational age with HIE were included; main outcomes were in-hospital death and discharge with abnormal or normal MRI.

Healthcare organizational factors associated with delayed therapeutic hypothermia in neonatal hypoxic-ischemic encephalopathy: the LyTONEPAL cohort.

Initiation of therapeutic hypothermia (TH) within 6 h of life is a major concern for treating neonatal hypoxic ischemic encephalopathy (HIE). We aimed to determine clinical and healthcare organizational factors associated with delayed TH in a French population-based cohort of neonates with moderate/severe HIE. Time to reach a rectal temperature of 34 °C defines optimal and delayed (within and over 6 h, respectively) TH.

Neurodevelopment at two years and appropriate schooling at five years in children born very preterm.

Aim: This single-centre French cohort study evaluated the relationship between standardised assessment at 2 years of corrected age and schooling level at 5 years of age in children born at ≤32 weeks' gestational age.

Methods: This was a single-centre retrospective study of children born preterm between 2010 and 2014 included in a follow-up network. At 5 years of age, the population was divided into 2 groups: (1) 'appropriate schooling', defined as age-appropriate schooling without support, and (2) 'schooling with support'.

Implementation of a Vancomycin Dose-Optimization Protocol in Neonates: Impact on Vancomycin Exposure, Biological Parameters, and Clinical Outcomes.

Vancomycin dosing used in neonates results frequently in insufficient concentrations. A vancomycin dose-optimization protocol consisting of an individualization of loading and maintenance doses (administered during continuous infusion) through a previously validated pharmacokinetic model was implemented in our center. This monocenter retrospective study aimed to compare vancomycin average concentration (Cavg) in the therapeutic range (15 to 25 mg/L) and biological and clinical parameters before and after implementation of this protocol.

Prevalence and risk factors of discomfort in infants with severe bronchiolitis.

Aim: The aim of this study was to assess the prevalence of discomfort in infants with severe bronchiolitis supported by noninvasive ventilation and to identify its potential risk factors.

Methods: A single-centre retrospective observational study. Discomfort was assessed using the EDIN (Echelle de Douleur et d'Inconfort du Nouveau-né) scale.

Cerebral injuries in neonatal encephalopathy treated with hypothermia: French LyTONEPAL cohort.

Background: Hypothermia is widely used for infants with hypoxic-ischemic neonatal encephalopathy but its impact remains poorly described at a population level. We aimed to describe brain imaging in infants born at ≥36 weeks' gestation, with moderate/severe encephalopathy treated with hypothermia.

Methods: Descriptive analysis of brain MRI and discharge neurological examination for infants included in the French national multicentric prospective observational cohort LyTONEPAL.

Mortality and significant neurosensory impairment in preterm infants: an international comparison.

Objective: To compare mortality and rates of significant neurosensory impairment (sNSI) at 18-36 months' corrected age in infants born extremely preterm across three international cohorts.

Design: Retrospective analysis of prospectively collected neonatal and follow-up data.

Setting: Three population-based observational cohort studies: the Australian and New Zealand Neonatal Network (ANZNN), the Canadian Neonatal and Follow-up Networks (CNN/CNFUN) and the French cohort Etude (Epidémiologique sur les Petits Ages Gestationnels: EPIPAGE-2).

Neurodevelopmental outcomes at age 5 among children born preterm: EPIPAGE-2 cohort study.

Objectives: To describe neurodevelopment at age 5 among children born preterm.

Design: Population based cohort study, EPIPAGE-2.

Setting: France, 2011.

Patent ductus arteriosus, tracheal ventilation, and the risk of bronchopulmonary dysplasia.

Background: An increased risk for bronchopulmonary dysplasia (BPD) exists when moderate-to-large patent ductus arteriosus shunts (hsPDA) persist beyond 14 days.

Goal: To examine the interaction between prolonged exposures to tracheal ventilation (≥10 days) and hsPDA on the incidence of BPD in infants <28 weeks gestation.

Study Design: Predefined definitions of prolonged ventilation (≥10 days), hsPDA (≥14 days), and BPD (room air challenge test at 36 weeks) were used to analyze deidentified data from the multicenter TRIOCAPI RCT in a secondary analysis of the trial.

Effect of Early Targeted Treatment of Ductus Arteriosus with Ibuprofen on Survival Without Cerebral Palsy at 2 Years in Infants with Extreme Prematurity: A Randomized Clinical Trial.

Objective: To examine the effects of early echocardiography-targeted ibuprofen treatment of large patent ductus arteriosus (PDA) on survival without cerebral palsy at 24 months of corrected age.

Study Design: We enrolled infants born at <28 weeks of gestation with a large PDA on echocardiography at 6-12 hours after birth to ibuprofen or placebo by 12 hours of age in a multicenter, double blind, randomized-controlled trial. Open-label ibuprofen was allowed for prespecified criteria of a hemodynamically significant PDA.

Influence of swaddling on tactile manual learning in preterm infants.

Background And Aim: Swaddling is a well-known technique in developmental care programs as there is some evidence that swaddling is an appropriate stress-reducing method for preterm infants in the NICU. However, no experimental study has investigated the influence of swaddling in a learning context. This study aimed to assess the impact of swaddling on tactile manual abilities in preterm infants.

Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA).

Background: One major limitation for less invasive surfactant administration (LISA) is the difficulty in providing sedation before this procedure and the competitive risk of respiratory depression versus avoidance of intubation for most sedative or analgesic drugs used in this context. The objective of this study is to compare the need for mechanical ventilation within 72 h of life following premedication with propofol, versus placebo (rescue with ketamine), for the LISA procedure in preterm neonates born before 32 weeks gestational age (wGA).

Methods: ProLISA is a phase III, non-inferiority, multicenter, double blind, randomized, placebo controlled trial designed according to the SPIRIT Statement.

Early extubation is not associated with severe intraventricular hemorrhage in preterm infants born before 29 weeks of gestation. Results of an EPIPAGE-2 cohort study.

Objective: To determine whether there is an association between severe intraventricular hemorrhage and early extubation in preterm infants born before 29 weeks of gestational age and intubated at birth.

Methods: This study included 1587 preterm infants from a nationwide French population cohort (EPIPAGE-2). Secondary data on intubated preterm infants were analyzed.

Bacteriological screening of breast milk samples destined to direct milk donation: Prospective evaluation between 2007 and 2016.

This study analyzes the bacteriological quality of breast milk samples destined to direct milk donation to preterm infants under 34 Gestational Weeks (GW) hospitalized in a neonatology and a neonatal intensive care unit of a French university hospital. All samples of breast milk destined to direct milk donation between April 2007 and December 2016 were included. A sample was defined as compliant if its total flora was less than 10 Colony Forming Units per milliliter (CFU/mL) and in the absence of Staphylococcus aureus and other pathogens.