Special Care and School Difficulties in 8-Year-Old Very Preterm Children: The Epipage Cohort Study

OBJECTIVES: To investigate school difficulties, special care and behavioral problems in 8 year-old very preterm (VPT) children. PATIENT AND METHODS: Longitudinal population-based cohort in nine regions of France of VPT children and a reference group born at 39-40 weeks of gestation (WG). The main outcome measures were information about school, special care and behavioral problems using Strengths and Difficulties Questionnaire from a questionnaire to parents. RESULTS: Among the 1439 VPT children, 5% (75/1439) were in a specialised school or class, 18% (259/1439) had repeated a grade in a mainstream class and 77% (1105/1439) were in the appropriate grade-level in mainstream class; these figures were 1% (3/327) , 5% (16/327) and 94% (308/327) , respectively, for the reference group. Also, 15% (221/1435) of VPT children in a mainstream class received support at school versus 5% (16/326) of reference group. More VPT children between the ages of five and eight years received special care (55% (794/1436)) than children born at term (38% (124/325)); more VPT children (21% (292/1387)) had behavioral difficulties than the reference group (11% (35/319)). School difficulties, support at school, special care and behavioral difficulties in VPT children without neuromotor or sensory deficits varied with gestational age, socioeconomic status, and cognitive score at the age of five. CONCLUSIONS: Most 8-year-old VPT children are in mainstream schools. However, they have a high risk of difficulty in school, with more than half requiring additional support at school and/or special care. Referral to special services has increased between the ages of 5 and 8 years, but remained insufficient for those with borderline cognitive scores

Socioeconomic deprivation and hospital length of stay: a new approach using area-based socioeconomic indicators in multilevel models

International audienceBACKGROUND: Socioeconomic deprivation is not easily measurable in hospital information systems. However, its identification is essential, as it is associated with morbidity and hospital length of stay (LOS). We aimed at studying the feasibility of using routinely recorded individual and area-based socioeconomic indicators, and assessing their relation with LOS. METHODS: In a cross-sectional study we collected area-based socioeconomic deprivation indicators from French census databases and individual ones from the 2009 medical and administrative databases of a French referral maternity hospital. The principal outcome was the LOS for delivery. Individual level socioeconomic deprivation indicators included preferential insurance scheme (health insurance allocated to poor persons). Nine area-based socioeconomic deprivation indicators were aggregated at the census tract and commune levels. The relation between socioeconomic deprivation and LOS was studied using multilevel models. The well-documented relation between socioeconomic deprivation and preterm delivery was firstly studied in these models as a validation step. RESULTS: The linkage between aggregated and individual data was possible for the 3471 women included. The median LOS was 5 days. In multivariable analysis adjusted for age (P=0.02), twinning (P=0.0001), delivery mode (P<0.0001), drug addiction (P<0.0001), diagnosis-related group severity level (P<0.0001), and unemployment rate (P=0.002) were associated with an increased LOS. CONCLUSIONS: Identifying deprived patients in hospital databases using routinely collected area-based indicators is feasible. The relation of these latter with LOS is consistent with previous studies. Further multicenter investigations are needed to confirm the interest of using such indicators for cost and morbidity predictions

Social deprivation and the use of healthcare services over one year by children less than 18 years of age in 2018: A French nationwide observational study.

This study aimed to describe the health status of children and how social deprivation affects their use of healthcare services and mortality. Children living in mainland France were selected from the national health data system (SNDS) on their date of birth or birthday in 2018 ( 1 night (rQ5/Q1 = 1.44). Psychiatric hospitalization was more frequent for children with CMUc (rCMUc/Not = 3.5, 0.7% vs 0.2%). Higher mortality was observed for deprived children < 18 years (rQ5/Q1 = 1.59). Our results show a lower use of pediatricians, other specialists, and dentists among deprived children that may be due, in part, to an insufficient supply of care in their area of residence. These results have been used to recommend optimization and specifically adapted individual or area-wide policies on the use of healthcare services, their density, and activities

Preterm births among male and female conception cohorts in France during initial COVID-19 societal restrictions

International audiencePurpose: A recent meta-analysis finds reduced risk of preterm birth (PTB; <37 weeks gestational age) during the initial stage of COVID-19 in which infection rates remained relatively low but many societies imposed restrictions on movement. None of this work, however, examines sex-specific responses despite much literature on other ambient "shocks" which would predict male sensitivity. We use a conception cohort approach to explore potential sex-specific PTB responses in France, a country which imposed a lockdown in Spring 2020.Methods: We applied interrupted time series methods using national data in France for 207 weeks among 1403,284 males and 1341,359 females conceived from 19 Jan 2016 to 6 Jan 2020.Results: For males in utero, the 1st COVID-19 societal lockdown corresponds with a - 0.60 per 100 conception reduction in PTB cases per week, for 12 consecutive weeks (95% confidence interval [CI]: -.36, -.84). For females in utero, the PTB reduction is smaller (-0.40 reduction per 100 conceptions, for 10 consecutive weeks, 95% CI: -.15, -.61). A formal test of sex differences in the PTB response indicates a stronger reduction in male (vs. female) PTB during the lockdown (p = .001).Conclusions: Explanations for the counterintuitive reduction in PTB during COVID-19 among cohorts in utero during Spring 2020 should consider mechanisms that disproportionately affect males

Impact of the COVID-19 pandemic on induced abortions in France in 2020

No abstract availabl

Ethics and observational studies in medical research: various rules in a common framework.

International audienceBACKGROUND: Research ethics have become universal in their principles through international agreements. The standardization of regulations facilitates the internationalization of research concerning drugs. However, in so-called observational studies (i.e. from data collected retrospectively or prospectively, obtained without any additional therapy or monitoring procedure) the modalities used for applying the main principles vary from one country to another. This situation may entail problems for the conduct of multi-centric international studies, as well as for the publication of results if the authors and editors come from countries governed by different regulations. In particular, several French observational studies were rejected or retracted by US peer-reviewed journals, because their protocols have not been submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC). METHODS: National legislation case analysis. RESULTS: In accordance with European regulation, French observational studies from data obtained without any additional therapy or monitoring procedure, do not need the approval of an IRB/IEC. Nevertheless, these studies are neither exempt from scientific opinion nor from ethical and legal authorization. CONCLUSION: We wish to demonstrate through the study of this example that different bodies of law can provide equivalent levels of protection that respect the same ethical principles. Our purpose in writing this article was to encourage public bodies, scientific journals and researchers to gain a better understanding of the various sets of specific national regulations and to speak a common language

Évaluation de la qualité métrologique des données du programme de médicalisation du système d'information (PMSI) en périnatalité: Étude pilote réalisthomampers

International audienceBackground: In order to assess public health policies for the perinatal period, routinely produced indicators are needed for the whole population. In France, these indicators are used to compare the national public health policy with those of other European countries. French administrative and medical data (PMSI) are straightforward and reliable and may be a valuable source of information for research. This study aimed to measure the quality of PMSI data from three university health centers for core indicators in perinatal health. Method: PMSI data were compared with medical files in 2012 from 300 live births after 22 weeks of amenorrhea, drawn at random from University Hospitals in Dijon, Paris and Nancy. The variables were chosen based on the Europeristat Project's core and recommended indicators, as well as those of the French National Perinatal survey conducted in 2010. The information gathered blindly from the medical files was compared with the PMSI data positive predictive value (PPV) and the sensitivity was used to assess data quality. Results: Data on maternal age, parity and mode of delivery as well as the rates of premature births were superimposable for the two sources. The PPV for epidural injection was 96.2% and 94.3% for perineal tears. Overall, maternal morbidity was underdocumented in the PMSI, so the PPV was 100.0% for pre-existing diabetes, 88.9% for gestational diabetes and 100.0% for high blood pressure with a rate of 9.0% in PMSI and 6.3% in the medical files. The PPV for bleeding during labor was 89.5%. Conclusion: To conclude, PMSI data are apparently becoming more and more reliable for two reasons: on one hand, the importance of these data for budgetary promotion in hospitals; on the other, the increasing use of this information for statistical and epidemiological purposes

Intrauterine Growth Restriction, Head Size at Birth, and Outcome in Very Preterm Infants

International audienceOBJECTIVES:To determine whether small head circumference (HC) or birth weight (BW) or both are associated with neonatal and long-term neurologic outcome in very preterm infants.STUDY DESIGN:All 2442 live births from the 1997 Epipage study between 26 and 32 weeks of gestational age in 9 regions of France were analyzed. A total of 1395 were tested at age 5 years for cognitive performance and 1315 with school performance reports at age 8 years. Symmetric growth restriction (SGR) was defined by HC and BW 20th percentile.RESULTS:Compared with appropriate for gestational age, SGR was significantly associated with neonatal mortality (aOR 2.99, 95% CI 1.78-5.03), moderate and severe cognitive deficiency (aOR 1.65, 95% CI 1.01-2.71 and aOR 2.61, 95% CI 1.46-4.68, respectively), and poor school performance (aOR 1.79; 95% CI 1.13-2.83). HGR was significantly associated with severe cognitive deficiency (aOR 2.07, 95% CI 1.15-3.74). WGR was not significantly associated with cognitive or school performance despite higher rates of neonatal morbidity.CONCLUSIONS:SGR in preterm infants was associated with neonatal mortality and impaired cognitive and school performance. The outcome of asymmetric growth restriction differed according to HC. HGR was associated with impaired cognitive function; WGR was not

Neonatal Mortality and Long-Term Outcome of Infants Born between 27 and 32 Weeks of Gestational Age in Breech Presentation: The EPIPAGE Cohort Study

International audienceObjectiveTo determine whether breech presentation is an independent risk factor for neonatal morbidity, mortality, or long-term neurologic morbidity in very preterm infants.DesignProspective population-based cohort.PopulationSingletons infants without congenital malformations born from 27 to 32 completed weeks of gestation enrolled in France in 1997 in the EPIPAGE cohort.MethodsThe neonatal and long-term follow-up outcomes of preterm infants were compared between those in breech presentation and those in vertex presentation. The relation of fetal presentation with neonatal mortality and neurodevelopmental outcomes was assessed using multiple logistic regression models.ResultsAmong the 1518 infants alive at onset of labor included in this analysis (351 in breech presentation), 1392 were alive at discharge. Among those eligible to follow up and alive at 8 years, follow-up data were available for 1188 children. Neonatal mortality was significantly higher among breech than vertex infants (10.8% vs. 7.5%, P = 0.05). However the differences were not significant after controlling for potential confounders. Neonatal morbidity did not differ significantly according to fetal presentation. Severe cerebral palsy was less frequent in the group born in breech compared to vertex presentation but there was no difference after adjustment. There was no difference according to fetal presentation in cognitive deficiencies/learning disabilities or overall deficiencies.ConclusionOur data suggest that breech presentation is not an independent risk factor for neonatal mortality or long-term neurologic deficiencies among very preterm infants