Author: Mélanie Durox

In this section you will find information that may be of interest to investigators participating in Treocapa. Newsletter : click on the NL to view it NL 17 – April 2023 NL 16 – March 2023 NL 15 – Feb 2023 NL 14 – Sept 2022 NL 13 – May 2022 NL 12 – April… Continue reading For Investigators

Frequently asked questions by parents for recruitment in the TREOCAPA study

Here you can download the parent information sheet for phase III of the study: Vous pouvez télécharger ici la notice d’information Parent de la phase III de l’étude : English French Aqui pode descarregar a ficha de informação dos pais para a fase III do estudo: Здесь вы можете скачать информационный лист для родителей для… Continue reading Patient information sheet – Phase III

Here you can download the parent information sheet for phase II of the study: English Vous pouvez télécharger ici la notice d’information Parent de la phase II de l’étude : French

INSERM, a biomedical French research institute, is the sponsor of the trial. The study is led by Professor Jean-Christophe Rozé, who is working in the Nantes University Hospital in France. INSERM: Founded in 1964, Inserm is a public scientific and technological institute which operates under the joint authority of the French Ministries of Health and… Continue reading Funding & sponsorship

How is it possible to measure the efficacy of the drug? In this study two different treatments will be compared to each other. This is to be achieved by one group receiving a placebo, which is an inactive substance e.g. a saline, which does no harm, and one group receiving the actual medication. Therefore, all… Continue reading Allocation of the participants in the study group

When will the participants be enrolled? Study enrolment and the first administration of either paracetamol or placebo must be given intravenously within the first 12 hours after birth. Which interventions are the participants receiving? During the first 5 days of life, further intravenous infusions will follow at 6-hourly intervals for 15 minutes each (total of… Continue reading Study procedure

When does the actual intervention start? Study enrolment and the first administration of paracetamol must be given intravenously within the first 12 hours after birth. What further treatments do the babies receive? During the first 5 days of life, further intravenous infusions (placing fluids into the bloodstream through a vein) will follow at6-hourly intervals for… Continue reading Study procedure