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BackgroundThe infant mortality rate (IMR) serves as a key indicator of population health.MethodsWe used data from the French National Institute of Statistics and Economic Studies on births and deaths during the first year of life from 2001 to 2019 to calculate IMR aggregated by month. We ran joinpoint regressions to identify inflection points and assess the linear trend of each segment. Exploratory analyses were performed for overall IMR, as well as by age at death subgroups (early neonatal [D0-D6], late neonatal [D7-27], and post-neonatal [D28-364]), and by sex. We performed sensitivity analyses by excluding deaths at D0 and using other time-series modeling strategies.ResultsOver the 19-year study period, 53,077 infant deaths occurred, for an average IMR of 3·63/1000 (4·00 in male, 3·25 in female); 24·4% of these deaths occurred during the first day of life and 47·8% during the early neonatal period. Joinpoint analysis identified two inflection points in 2005 and 2012. The IMR decreased sharply from 2001 to 2005 (slope: -0·0167 deaths/1000 live births/month; 95%CI: -0·0219 to -0·0116) and then decreased slowly between 2005 and 2012 (slope: -0·0041; 95%CI: -0·0065 to -0·0016). From 2012 onwards, a significant increase in IMR was observed (slope: 0·0033; 95%CI: 0·0011 to 0·0056). Subgroup analyses indicated that these trends were driven notably by an increase in the early neonatal period. Sensitivity analyses provided consistent results.InterpretationThe recent historic increase in IMR since 2012 in France should prompt urgent in-depth investigation to understand the causes and prepare corrective actions.FundingNo financial relationships with any organizations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work.

Background: Persistent patency of the ductus arteriosus (PDA) has challenged neonatologists for more than 40 years. Controversies persist about the management of PDA in extremely preterm infants. PDA is associated with morbidities, but no therapeutic strategy has resulted in an improved neonatal outcome. Acetaminophen appears to be a promising alternative with possibly fewer adverse effects. The primary objective is to determine whether a prophylactic pharmacological intervention with acetaminophen may increase the survival without severe morbidity at postmenstrual age of 36 weeks. Methods and analysis: TREOCAPA phase III is a randomized, multicenter, double-blind, stratified, placebo-controlled superiority trial, two arms in a 1:1 ratio performed in 43 NICUs of 14 European countries, evaluating whether the intervention increases the survival without severe morbidity by 10%, from 50% in control arm to 60% in treatment arm, until the age of 36 postmenstrual weeks. To detect this difference, 794 patients were required using a group sequential design. Recruitment has been closed, with 803 patients enrolled. Patients eligible for inclusion are preterm infants with a gestational age between 23 and 28 weeks. In the acetaminophen group, 20 mg/kg loading dose within 12 h after birth, followed by 7.5 mg/kg quarter in die (QID) for 5 days, will be administered to the 27–28 weeks gestational age group, and 25 mg/kg loading dose then 10 mg/kg QID will be administered to the 23–26 weeks gestational age group. The severe morbidities include severe bronchopulmonary dysplasia (BPD grade 3) according to NIH consensus, necrotizing enterocolitis (NEC) of Bell's stage II or III, intraventricular hemorrhage (IVH) grade III–IV according to Papile classification, or cystic leukomalacia. Discussion: Whatever the results, the conclusions of this study should be informative for the neonatal scientific community. The results will either confirm the benefit of treatment in increasing survival without severe morbidity, or indicate a worsening of outcomes with prophylactic acetaminophen treatment, or show no difference in the primary outcome. In the latter case, ultrasonographic assessments of ductus arteriosus status on day 7 may help explain the absence of a difference. This could indicate that acetaminophen is ineffective in promoting ductal closure or that early closure of the ductus arteriosus is inconsequential if, despite more frequent closures, there is no associated improvement in outcomes. Ethics and dissemination: Ethical approval of the trial has been performed in each of the 14 countries after approval, at the European level, by the Voluntary Harmonization Procedure committee on 04/07/2020. Results will be disseminated through articles in peer-reviewed journals. Trial registration: European Clinical Trials Database: EudraCT Number: 2019–004297-26. ClinicalTrials.gov: NCT04459117, registered on July 7, 2020. [ABSTRACT FROM AUTHOR]

Aim: Prematurity is a risk factor for strabismus, but the roles of intermediate factors like retinopathy of prematurity (ROP) and neurological lesions are less understood. We aimed to identify neonatal risk factors for strabismus at age 5.5 in preterm children. Methods: Data were extracted from the étude épidémiologique sur les petits âges gestationnels 2 cohort, a French prospective population‐based study of preterm children born in 2011 with gestational age of 34 weeks or less. Strabismus was recorded during a medical interview at 5.5 years. Using a directed acyclic graph, intermediate and confounding factors were identified. Total and direct effects of gestational age on strabismus risk were analysed using generalised estimating equation. Results: Among 2419 children assessed, 274 (52.6% male) presented strabismus at 5.5 years. The direct effect of gestational age remained significant after adjustment (p < 0.001). In the complete imputed model: maternal smoking during pregnancy (odds ratio, OR 1.8; 95% confident interval, 95% CI 1.3–2.6), neonatal severe cerebral lesions (OR 2.9, 95% CI 1.8–4.6) and severe ROP (OR 4.2, 95% CI 1.9–9.0) were independent risk factors. Conclusion: Special attention is needed regarding strabismus screening at age 5.5 in preterm children, even without severe cerebral lesions and ROP. Smoking cessation during pregnancy should be encouraged. [ABSTRACT FROM AUTHOR]

Background: Few studies evaluated the use of Household Disinfectant and Cleaning Products (HDCPs) during the COVID-19 pandemic, but no population-based cohorts used longitudinal data. We studied changes in HDCPs during the first lockdown, based on longitudinal data from the French population-based NutriNet-Santé and CONSTANCES cohorts. Methods: Based on standardized questionnaires on household cleaning tasks in 2018–2019 and around the first lockdown in France (March17-May3 2020), we compared the duration of weekly use of HDCPs (< 1 day/week, < 10 min/week; 10-30 min/week; > 30 min/week) and the household cleaning help (yes/no) before and during the lockdown period by Bhapkar and McNemar's tests. Moreover, we assessed self-reported changes in the frequency of HDCPs during the lockdown from before (unchanged/increased). Results: Analyses were carried on 31,105 participants of NutriNet-Santé (48 years, 75% women, 81% ≥ high school diploma) and 49,491 of CONSTANCES (47 years, 51% women, 87% ≥ high school diploma). During the lockdown, compared with 2018–2019, duration of HDCPs use increased (> 30 min; NutriNet-Santé: 44% versus 18%; CONSTANCES: 63% versus 16%) and household help decreased (NutriNet-Santé: 5% versus 40%; CONSTANCES: 3% versus 56%). Regarding the frequency of HDCPs use, 55% of participants of NutriNet-Santé (57% women/49% men) and 83% of CONSTANCES (86% women/81% men) reported an increased use since the beginning of the lockdown, significantly higher among women (p < 0.0001). Conclusions: The frequency and duration of weekly use of HDCPs has significantly increased since the pandemic. As the use of HDCPs is associated with health issues, further studies are now needed to evaluate the potential health impacts of these changes. [ABSTRACT FROM AUTHOR]

The individual results of SARS-CoV-2 serological tests measured after the first pandemic wave of 2020 cannot be directly interpreted as a probability of having been infected. Plus, these results are usually returned as a binary or ternary variable, relying on predefined cut-offs. We propose a Bayesian mixture model to estimate individual infection probabilities, based on 81,797 continuous anti-spike IgG tests from Euroimmun collected in France after the first wave. This approach used serological results as a continuous variable, and was therefore not based on diagnostic cut-offs. Cumulative incidence, which is necessary to compute infection probabilities, was estimated according to age and administrative region. In France, we found that a "negative" or a "positive" test, as classified by the manufacturer, could correspond to a probability of infection as high as 61.8% or as low as 67.7%, respectively. "Indeterminate" tests encompassed probabilities of infection ranging from 10.8 to 96.6%. Our model estimated tailored individual probabilities of SARS-CoV-2 infection based on age, region, and serological result. It can be applied in other contexts, if estimates of cumulative incidence are available. [ABSTRACT FROM AUTHOR]

Objective: To develop and validate a clinical prediction model for outcomes at 5 years of age for children born extremely preterm and receiving active perinatal management. Design: The EPIPAGE‐2 national prospective cohort. Setting: France, 2011. Population: Live‐born neonates between 24+0 and 26+6 weeks of gestation who received active perinatal management (i.e. birth in a tertiary‐level hospital, with antenatal steroids and resuscitation at birth). Methods: A prediction model using logistic modelling, including gestational age, small‐for gestational‐age (SGA) status and sex, was developed. Model performance was assessed through calibration and discrimination, with bootstrap internal validation. Main outcome measures: Survival without moderate or severe neurodevelopmental disability (NDD) at 5 years. Results: Among the 557 neonates included, 401 (72%) survived to 5 years, of which 59% survived without NDD (95% CI 54% to 63%). Predicted rates of survival without NDD ranged from 45% (95% CI 33% to 57%), to 56% (95% CI 49% to 64%) to 64% (95% CI 57% to 70%) for neonates born at 24, 25 and 26 weeks of gestation, respectively. Predicted rates of survival without NDD were 47% (95% CI 18% to 76%) and 62% (95% CI 49% to 76%) for SGA and non‐SGA children, respectively. The model showed good calibration (calibration slope 0.85, 95% CI 0.54 to 1.16; calibration‐in‐the‐large −0.0123, 95% CI −0.25 to 0.23) and modest discrimination (C‐index 0.59, 95% CI 0.53 to 0.65). Conclusions: A simple prediction model using three factors easily known antenatally may help doctors and families in their decision‐making for extremely preterm neonates receiving active perinatal management. [ABSTRACT FROM AUTHOR]