PRETTINEOPREmedication Trial for Tracheal Intubation of the NEOnate - PRETTINEO

Phase 1

Conditions: Comparison of two premedication regimens for semi-elective or elective intubation of newborns (term and preterm) hospitalized in the NICU
MedDRA version: 13.1Level: PTClassification code 10067450Term: Endotracheal intubationSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 13.1Level: PTClassification code 10036500Term: PremedicationSystem Organ Class: 10042613 - Surgical and medical procedures

Registration Number: EUCTR2009-014885-25-FR

Lead Sponsor: Centre Hospitalier Intercommunal de Créteil

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Any newborn (corrected age < 28 days) hospitalized in a participating neonatal intensive care unit requiring semi-elective or elective endotracheal intubation Reliable and efficient IV access
Informed parental consent obtained
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

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) < corrected gestational age (in weeks) or as a capillary refill time > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>;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 <br>;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

Secondary Outcome Measures