Phase 3
N=173
Premedication Trial for Tracheal Intubation of the NEOnate
Premedication · Endotracheal Intubation
Bottom Line
View on ClinicalTrials.gov: NCT01490580 ↗Enrolled (actual)
173
Serious AEs
15.3%
Results posted
Sep 2019
Primary outcome: Primary: Number of Patients With Prolonged Desaturation — 54; 53 Participants — p=0.38
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- atropine+ propofol (Drug); atropine + atracurium + sufentanil (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Centre Hospitalier Intercommunal Creteil
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Prolonged Desaturation |
54; 53 | 0.38 |
| SECONDARY Number of Intubation Attempts |
41; 47; 25; 23; 21; 11 | — |
| SECONDARY Duration of Intubation Procedure |
6.0; 3.5 | — |
| SECONDARY Heart Rate |
3.3; 11.5; 1.6; 11.7 | — |
| SECONDARY Short Term Neurological Outcome: Worsening of Head Ultrasound |
14; 12 | — |
| SECONDARY Number of Patients Surviving Without Ages and Stages Questionnaire Score Below Threshold at Age 2 |
38; 45 | — |
| SECONDARY Pulse Oxymetry |
-6.0; -12.0; -8.7; -15.9 | — |
| SECONDARY Mean Blood Pressure |
-6.8; 0.2; -9.1; -3.3 | — |
| SECONDARY Transcutaneous PCO2 (TcPCO2) Measurement |
8.0; 14.1; 5.1; 16.2 | — |
Summary
Multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.
Primary outcome: pulse oxymetry value < 80% for more than 60 seconds. Secondary outcomes: number of attempts, duration of the procedure, changes in physiologic parameters, short- and long-term neurodevelopmental outcome.
Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" will significantly reduce the frequency of severe hypoxemia.
Eligibility Criteria
Inclusion Criteria
- Corrected age 3 seconds
- Upper airway malformation
- Life-threatening situation requiring immediate intubation
- Inclusion in another trial not permitting any other participation
- Impossibility to establish venous access
- Any contra-indication to any experimental drug
Data sourced from ClinicalTrials.gov (NCT01490580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.