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Abstract
Objective To determine whether birth outside a level-3 centre (outborn) is associated with a difference in the combined outcome of mortality or moderate-to-severe neurological impairment at 5.5 years of age compared with birth in a level-3 centre (inborn) when antenatal steroids and gestational age (GA) are accounted for.
Design Individual matched study nested within a prospective cohort. Each outborn infant was matched using GA and antenatal steroids with a maximum of four inborns. Conditional logistic regression was used to calculate ORs before being adjusted using maternal and birth characteristics. Analyses were carried out after multiple imputation for missing data.
Setting EPIPAGE-2 French national prospective cohort including births up to 34 weeks GA inclusive.
Patients Outborn and inborn control infants selected between 24 and 31 weeks GA were followed in the neonatal period and to 2 and 5.5 years. 3335 infants were eligible of whom all 498 outborns and 1235 inborn infants were included—equivalent to 2.5 inborns for each outborn.
Main outcome measure Survival without moderate-to-severe neurodevelopmental impairment at 5.5 years.
Results Chorioamnionitis, pre-eclampsia, caesarian birth and small-for-dates were more frequent among inborns, and spontaneous labour and antepartum haemorrhage among outborns. There was no difference in the main outcome measure at 5.5 years of age (adjusted OR 1.09, 95% CI 0.82 to 1.44); sensitivity analyses suggested improved outcomes at lower GAs for inborns.
Conclusion In this GA and steroid matched cohort, there was no difference in survival without moderate-to-severe neurodevelopmental impairment to 5.5 years of age between inborn and outborn very preterm children. This suggests steroids might be important in determining outcomes.
- Mortality
- Neonatology
- Epidemiology
Data availability statement
Data are available on reasonable request. The EPIPAGE-2 data are accessible to all research teams, public or private, French or foreign, subject to authorisation by the cohort Data Access Committee. The 2016 law for modernisation of the French Public Health System provides a legal framework for access to and reuse of already collected cohort data by complying with ‘Reference Methodology MR-004’. Only non-nominative data defined as having a low risk of reidentification are freely accessible. All data access requests must be submitted to the EPIPAGE 2 Data Access Committee; this committee evaluates the research projects based on the following criteria: (1) methodological strengths and weaknesses (feasibility, choice of methods to achieve the objectives); (2) absence of overlap with other ongoing projects - in caseof overlap, discussions with the different teams are organised; (3) relevance of the requested data for the project and respect for confidentiality. The study protocol, the data access charter and the data access procedure can be found on the EPIPAGE-2 website (https://epipage2.inserm.fr/index.php/fr/cote-recherche/235-acces-aux-donnees-et-questionnaires). Questionnaires and data catalogues are available at (https://pandora-epipage2.inserm.fr/public/).
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Data availability statement
Data are available on reasonable request. The EPIPAGE-2 data are accessible to all research teams, public or private, French or foreign, subject to authorisation by the cohort Data Access Committee. The 2016 law for modernisation of the French Public Health System provides a legal framework for access to and reuse of already collected cohort data by complying with ‘Reference Methodology MR-004’. Only non-nominative data defined as having a low risk of reidentification are freely accessible. All data access requests must be submitted to the EPIPAGE 2 Data Access Committee; this committee evaluates the research projects based on the following criteria: (1) methodological strengths and weaknesses (feasibility, choice of methods to achieve the objectives); (2) absence of overlap with other ongoing projects - in caseof overlap, discussions with the different teams are organised; (3) relevance of the requested data for the project and respect for confidentiality. The study protocol, the data access charter and the data access procedure can be found on the EPIPAGE-2 website (https://epipage2.inserm.fr/index.php/fr/cote-recherche/235-acces-aux-donnees-et-questionnaires). Questionnaires and data catalogues are available at (https://pandora-epipage2.inserm.fr/public/).
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Footnotes
Contributors P-YA and FG obtained funding for EPIPAGE-2 and initiated the cohort and follow-up. This research project was conceived by PJ and ASM, and further developed with input from CD, JF and TD. Initial analyses were performed by LM-M in discussion with ASM, PJ, TD and complementary analyses were conducted by LM-M in conjunction with ASM. The first draft of the paper was written by PJ and ASM, with critical review and input from all other authors. All authors critically revised the manuscript and agreed to the published version of the manuscript. ASM and PJ supervised all aspects of the work; ASM is the guarantor.
Funding The project has been funded with support from: (1) The French Institute of Public Health Research/Institute of Public Health and its partners: the French Health Ministry, the National Institute of Health and Medical Research (INSERM), the National Institute of Cancer, and the National Solidarity Fund for Autonomy (CNSA). (2) The National Research Agency through the French EQUIPEX program of investments in the future (reference ANR-11-EQPX-0038 and ANR-19-COHO-001). (3) The PREMUP Foundation. (4) Fondation de France (Reference 11779). (5) Fondation pour la Recherche Médicale (SPF20160936356—ASM). (6) Programme Hospitalier de Recherche Clinique Epinutri (DGOS13-040). (7) Ministère de l'Enseignement Supérieur, De La Recherche et de L'Innovation (G13129KK). (8) Apicil Foundation (R20065KK).
Competing interests Neil Marlow declares consultancy fees from Novartis and InfanDx GMBH during the past 5 years. There are no other competing interests.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
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