NCT01490580

Premedication Trial for Tracheal Intubation of the NEOnate

Double Blind Randomized Controlled Trial Comparing "Atropine+Propofol" Versus "Atropine+Atracurium+Sufentanil" as a Premedication Prior to Semi-urgent or Elective Endotracheal Intubation of Term and Preterm Newborns

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Premedication
• Endotracheal Intubation

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: 2012-05-01
• Primary completion: 2016-08-01
• Completion: 2020-04-15
• First posted: 2011-12-13
• Last updated: 2021-03-04
• Results posted: 2019-09-13

Locations

6 sites across 1 country: France