Bouazza, Naïm
Cambonie, Gilles
Flamant, Cyril
Rideau, Aline
Tauzin, Manon
Patkai, Juliana
Gascoin, Géraldine
Lumia, Mirka
Aikio, Outi
Lui, Gabrielle
Bournaud, Léo Froelicher
Walsh-Papageorgiou, Aisling
Tortigue, Marine
Baruteau, Alban-Elouen
Kallio, Jaana
Hallman, Mikko
Diallo, Alpha
Levoyer, Léa
Treluyer, Jean-Marc
Roze, Jean-Christophe
Clinical trials referenced in this document:
Documents that mention this clinical trial
Prophylactic Intravenous Acetaminophen in Extremely Premature Infants: Minimum Effective Dose Research by Bayesian Approach
https://doi.org/10.1007/s40272-023-00602-w
Funding for this research was provided by:
Innovative Medicines Initiatives 2 Join (Grant Agreement n°777389)
Article History
Accepted: 10 October 2023
First Online: 17 November 2023
Declarations
:
: Naïm Bouazza, Gilles Cambonie, Cyril Flamant, Aline Rideau, Manon Tauzin, Juliana Patkai, Géraldine Gascoin, Mirka Lumia, Outi Aikio, Gabrielle Lui, Léo Froelicher Bournaud, Aisling Walsh-Papageorgiou, Marine Tortigue, Alban-Elouen Baruteau, Jaana Kallio, Mikko Hallman, Alpha Diallo, Léa Levoyer, Jean-Marc Treluyer And Jean-Christophe Roze declare that they have no potential conflicts of interest that might be relevant to the contents of this manuscript.
: The trial was approved by ethics committee of Centre Hospitalier La Chartreuse under the number approval SI 20.03.09.40128 for France and by the regional medical research ethics committee of North Ostrobothnia under the number approval 68/06.00.00/20 19 for Finland.
: The data that support the findings of this study are available from Institut national de la santé et de la recherche médicale (Inserm), but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Inserm.
: NB, AD, LL and JC had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: NB, MH, JMT, JCR. Acquisition, analysis, or interpretation of data: NB, AD, LL and JCR Drafting of the manuscript: NB, LL, JCR. Critical revision of the manuscript for important intellectual content: all authors.
: Institut national de la santé et de la recherche médicale (Inserm) is the sponsor of the Treocapa trial. The project leading to this application has received funding through the Connect4Children consortium from the Innovative Medicines Initiatives 2 Join Undertaking under Grant Agreement no. 777389. This Joint Undertaking receives the support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
: The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The publication reflects the author's view and neither Innovative Medicines Initiatives (IMI) nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.
: Written informed consent was obtained from both parents.
: Not applicable.
: Not applicable.