Funding for this research was provided by:
Ministère des Affaires Sociales et de la Santé (2013 13-0327)
Article History
Received: 11 June 2018
Accepted: 19 July 2018
First Online: 1 August 2018
Ethics approval and consent to participate
: For each eligible neonate, an information form was delivered to parents. A first oral consent to participate were requested by the neonatologist at the inclusion concerning the baseline data collection during hospitalization. If this consent was not obtained, the parents signed the information form to refuse their participation. In this case and according to French regulations, these neonates were registered in the inventory of non-included eligible neonates with the collection of anonymous minimal data.At the end of the neonatal hospitalization a second but written consent was requested to participate to the standardized follow-up, and was signed by both parents and the neonatologist. Babies of parents who refused to participate were followed-up according to the usual practices of the center. According to French regulations, parents have a permanent right of access and rectification to their personal data, and can also leave the cohort at any time.According the French law, the study protocol, including ethics and consent to participate, was approved by the Advisory National Committee on the treatment of personal health data for research purposes (Comité Consultatif sur le Traitement de l’Information en matière de Recherche sur la Santé, approval granted November 20, 2014; reference number 14.724. The authorizations were obtained: UnorderedList removed
: Not applicable (anonymous and collective data only).
: The authors declare that they have no competing interests.
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