Comparison of two premedication regimens for semi-elective or elective intubation of newborns (term and preterm) hospitalized in the NICU MedDRA version: 13.1 Level: PT Classification code 10067450 Term: Endotracheal intubation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 13.1 Level: PT Classification code 10036500 Term: Premedication System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: atropine
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: tracriu
Sponsors
Centre Hospitalier Intercommunal de Créteil
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any newborn (corrected age =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: No parental consent Previous sedative or analgesic treatment administration in the past 24 hours Hemodynamic compromise defined as mean arterial blood pressure (in mm Hg) 3 seconds Obvious upper airway malformation making intubation potentially difficult Life threatening situation requiring immediate intubation without premedication Participation to another therapeutic clinical trial disallowing any other therapeutic trial Impossibility to have reliable and safe IV access
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to show that propofol, when compared to the association of atropine-atracurium-sufentanil as a premedication prior to endotracheal intubation, will decrease the number of desaturations defined as transcutaneous O2 saturation value below 80% for one minute or more ;Secondary Objective: Total duration of intubation, number of attempts and vital signs variations will be analyzed and compared between groups. Short term neurological surveillance will be based on head ultrasounds performed before and after intubation. For longer term outcome, a neurodevelopmental assessment will be performed in each center. If clinical evaluation is impossible, a phone survey will be performed at 4 months, one year and two years corrected age according to a standardized questionnaire ;Primary end point(s): Number of desaturations during the intubation procedure. Desaturations are defined as transcutaneous O2 saturation value below 80% for one minute or more | — |
Countries
France
Outcome results
None listed