Status:
UNKNOWN
Intranasal Midazolam Versus Intranasal Ketamine to Sedate Newborns for Intubation in Delivery Room
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Respiratory Distress Syndrome
Prematurity of Fetus
Eligibility:
All Genders
Up to 2 years
Phase:
PHASE3
Brief Summary
Anesthesia is rarely used to intubate newborns in delivery room because of the very difficulty of accessing veins. The investigators hypothesized that intranasal administration of sedative would be an...
Detailed Description
Randomized, double blind prospective multicenter study. Patients:-Inclusion criteria: (1) neonates in delivery room (2) Presence of repiratory distress syndrom requiring intubation (Silverman score\> ...
Eligibility Criteria
Inclusion
- Neonates in delivery room
- Presence of respiratory distress syndrom requiring intubation (Silverman score\> 3 and / or FiO2 greater than 30 % in premature infants under 30 weeks and over 40% after 30 weeks
- Hemodynamic stability (mean arterial pressure\> 3° percentile)
Exclusion
- Need for intubation in extreme emergency (pneumothorax, meconium aspiration, congenital diaphragmatic hernia, perinatal asphyxia)
- Birth in the absence of an independent appraiser
- Mother under general anesthesia
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01517828
Start Date
January 1 2012
End Date
May 1 2016
Last Update
December 3 2014
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Universitaire
Montpellier, France, 34000
2
Centre Hospitalier Universitaire
Nîmes, France, 30000
3
Centre Hospitalier Général
Perpignan, France, 66000