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Premedication Trial for Tracheal Intubation of the NEOnate

NCT01490580 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2021-03-04

Study results available
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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

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

Sponsors & Collaborators

  • Association Clinique Thérapeutique Infantile du val de Marne

    collaborator OTHER

  • Centre Hospitalier Intercommunal Creteil

    lead OTHER

Principal Investigators

  • Xavier Durrmeyer, MD · CHI CRETEIL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-08-31
Completion
2020-04-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01490580 on ClinicalTrials.gov