Intranasal Midazolam versus intranasal Ketamine to sedate newborns for intubation in delivery room
- Conditions
- Maladie des membranes hyalines du nouveau-né (Code CIM : P22.OX-001)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2011-003216-23-FR
- Lead Sponsor
- CHRU MONTPELLIER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
(1) neonates in delivery room (2) Presence of repiratory 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 (3) hemodynamic stability (mean arterial pressure> 3° percentile)
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
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
(1) Need for intubation in extreme emergency (pneumothorax, meconium aspiration, congenital diaphragmatic hernia, perinatal asphyxia) (2) Birth in the absence of an independent appraiser (3) mother under general anesthesia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): -The clinical pain score will be evaluated on film a posteriori by two independent observers using a scale of hetero pain assessment.<br><br>;Main Objective: To compare newborns sedation quality as they are sedated either by intranasal Midazolam or by intranasal Ketamine during intubation in delivery room.;Secondary Objective: To compare intubation quality, hemodynamic and respiratory tolerance, and neurological outcomeat 2 years within the two groups.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -The quality of intubation will be judged by the number of attempts required and by the duration of glottis exposure. <br>-Pain will be evaluated through the study of skin conductance.<br>-Hemodynamic and respiratory tolerances will be judged by measuring respectively variations in blood pressure, heart rate, FiO2 and the oxygen saturation. The neurological follow-up will be carried out according to Brunet-Lezine developmental scale at the age of 2 years.