ne analgésie de choix pour l'intubation des nouveau-nés : Etude multicentrique randomisée comparant le rémifentanil à l'association morphine-midazolam

• Conditions: Preterm newborn & newborm requiring an elective endotacheal intubation; MedDRA version: 12.0Level: LLTClassification code 10067450Term: Endotracheal intubation

• Registration Number: EUCTR2009-014256-30-BE
• Lead Sponsor: Hôpital Universitaire Des Enfants Reine Fabiola

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-18
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Every newborn admitted in the NICU with a gestational age equal or greater than 28 weeks and needing non-urgent endothracheal intubation for different pathologies (eg. Respiratory distress, infection, cardiorespiratory insufficiency)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Newborns :
a) With a gestational age lower than 28 weeks.
b) Needing endothracheal intubation in an emergency
c) With severe intraventricular hemorragy (grade 3-4)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified