Cerebral NIRS Profiles During Premedication for Neonatal Intubation

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02700893
Study type	Interventional
Source	Centre Hospitalier Intercommunal Creteil
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	March 2016
Completion date	August 2016

View Details

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