Overview

Cerebral NIRS Profiles During Premedication for Neonatal Intubation

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a 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: - Cerebral desaturation defined by a rScO2 delta >20% from the baseline value (before premedication). - Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 . Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Collaborators:
Association Clinique et Thérapeutique du Val de Marne
Association Clinique Thérapeutique Infantile du val de Marne
Centre de Recherche Clinique du CHIC
Treatments:
Atracurium
Atropine
Propofol
Sufentanil