Funding for this research was provided by:
Ministère des Affaires Sociales et de la Santé (PHRC-15-626)
Received: 16 July 2021
Accepted: 18 August 2021
First Online: 13 September 2021
: The expected sponsor is represented by the <i>Assistance Publique - Hôpitaux de Marseille</i> and must have approvals from the French authorities prior to the study’s initiation. The sponsor and the investigators conduct the study in accordance with Good Clinical Practices and the French applicable regulatory requirements (Public Health Act No. 2004–806 of August 9, 2004 on public health policy and its implementing decrees of August 27, 2006 [<i>Code de la Santé Publique, article L.1121–1</i>]), as the applicable privacy requirements and ethical principles outlined in the Declaration of Helsinki. This study was approved by the French Ethics Committee (<i>Comité de Protection des Personnes Sud Méditerranée V</i>) on April 12, 2016 and by the French National Agency for Medicines and Health Products Safety (<i>Agence Nationale de Sécurité du Médicament et des Produits de Santé</i>) on April 18, 2016 (reference number ID-RCB:2016-A00122–49 – Protocol version 2 of 29 Mars 2016). All amendments will be submitted to these two French organizations and communicated to investigators associated by sponsor. The study was registered in ClinicalTrials.gov (NCT02757794).In accordance with applicable regulations including Good Clinical Practices, and Sponsor’s procedures, a Sponsor’s monitor will visit the investigator before, during and after the study. Sponsor’s monitors will contact the site prior to the start of the study to review with the site staff the protocol, study requirements, and their responsibilities to satisfy regulatory, ethical, and Sponsor’s requirements. When reviewing data collection procedures, the discussion will also include identification, agreement and documentation of data items for which the case report form will serve as the source document. The type and frequency of monitoring are determined using the definition of the level of monitoring based on patient risk and depend on the number of patients included, the rate of inclusions and difficulties encountered during the conduct of the study (procedures approved by the group quality promotion which determines the level of monitoring to be carried out based on risk to the subject-OECD recommendation on the Governance of Clinical Trials, December 2012). In this study, the level of monitoring is rated “minimal” with a risk for the patient level A. The Sponsor’s monitor will verify the signed informed consents. If one / multiple consents are not compliant, files will be monitored randomly. All adverse events occurring during clinical trial have to be collected, verified, registered and reported from Day 0 (inclusion day for the participant) until the last day of the study, or as soon as the investigator becomes aware of the AE that he considers linked to the protocol and this up to its resolution.Any publication must state that <i>Assistance Publique - Hôpitaux de Marseille</i> is the promoter and the study’s databases will be co-owned by the promoter <i>Assistance Publique - Hôpitaux de Marseille</i> and by the INSERM U1153, EPOPÉ team. The results, as well as all research-related data, must under no circumstances be transmitted to third parties without compensation negotiated beforehand by the Medical Research Branch of the <i>Assistance Publique - Hôpitaux de Marseille</i> and/or INSERM U 1153.All data, results, inventions and discoveries resulting from the study will automatically become the exclusive property of the sponsor which may use this information in the manner deemed suitable with the agreement of the investigator.The EPIREMED study is part of EPIPAGE 2 and allows us to benefit from the collaboration of those involved in the EPIPAGE 2 cohort’s steering committee. The different investigators are involved in the monitoring and care of very premature babies. Their diverse training and responsibilities meet all aspects of our project. These investigators are either pediatrician-neonatologists or pediatric neurologists working in type III neonatal units, in neuro-pediatric services for very premature infants’s assessment or in a referral center for learning disabilities.A written informed consent will be obtained from two parents or legal representative to children participating in the study. Protection of the rights will be guaranteed, and anonymity maintained. In accordance with French laws and regulations respectively, all patient records identities will remain confidential. The study’s results will be disseminated to patients via a written report in a clear and accessible language.
: Not applicable.
: The authors declare that they have no competing interests.