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Authors
Bertholet-Thomas, Aurélia
Portefaix, Aurélie
Flammier, Sacha
Dhelens, Carole
Subtil, Fabien
Dubourg, Laurence
Laudy, Valérie
Le Bouar, Myrtille
Boussaha, Inesse
Ndiaye, Marietou
Molin, Arnaud
Lemoine, Sandrine
Bacchetta, Justine https://orcid.org/0000-0002-0578-2529
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Funding
Funding for this research was provided by:
Direction Générale de l’offre de Soins
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Article History
Received: 21 October 2021
Accepted: 13 April 2022
First Online: 16 June 2022
Declarations
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: The study protocol was first approved by the Ethic committee <i>EC Nord Ouest I</i> on December 14, 2020 (20.09.22.57341), and then on June 17, 2021 (20.00146.057341-MS01), after substantial modifications and by the French competent authority (<i>Agence Nationale de Sécurité du Médicament et des produits de santé</i>, ANSM) on November 24, 2020 (MEDAECPP-2020-09-00014), and then on June 30, 2021 (MEDMSANAT-2021-06-0053_2020-003011-97). This approval applies for all participating centers. It is registered under EudraCT number 2020-003011-97. The study is compliant with the reference methodology of <i>Commission Nationale de l’Informatique et des Libertés</i>. The study is conducted in accordance with the French legislation, the Good Clinical Practice, and the Declaration of Helsinki.The parents/legal guardians of the child are informed, orally and through the information sheet given at the preoperative interview. Patient/parents/legal guardians are requested to sign the informed consent before any study procedure is performed (before randomization). A sufficient time is left to the patient/parents/legal guardians for decision to participate.
: Not applicable.
: The authors declare that they have no competing interests.
