Overview

Premedication Trial for Tracheal Intubation of the NEOnate

Status:
Completed
Trial end date:
2020-04-15
Target enrollment:
Participant gender:
Summary
Multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate. Primary outcome: pulse oxymetry value < 80% for more than 60 seconds. Secondary outcomes: number of attempts, duration of the procedure, changes in physiologic parameters, short- and long-term neurodevelopmental outcome. Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" will significantly reduce the frequency of severe hypoxemia.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Collaborators:
ACTIV (Association Clinique et Thérapeutique du Val de Marne)
Association Clinique Thérapeutique Infantile du val de Marne
CRC (Centre de Recherche Clinique) du CHIC
Treatments:
Atracurium
Atropine
Propofol
Sufentanil