NCT02700893

Cerebral NIRS Profiles During Premedication for Neonatal Intubation

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Premedication
• Endotracheal Intubation
• Cerebral Hypoperfusion

Interventions

Type	Name	Description
DRUG	atropine+ propofol	Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants \< 1000g - Renewable once 2.5 mg/kg for infants \> 1000G - Possible additional dose of 1 mg/kg
DRUG	atropine + atracurium + sufentanil	Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants \< 1000g 0.2 µg/kg for infants \> 1000g

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-03-07
• Last updated: 2019-08-09

Locations

2 sites across 1 country: France