Premedication Trial for Tracheal Intubation of the NEOnate
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.
Timeline
- Start
- 2012-05
- Primary completion
- 2016-08
- Completion
- 2020-04-15
Outcome
Missed primary endpoint
registry analysis (superiority test); Atropine Atracurium Sufentanil vs Atropine Propofol; p = 0.38; Risk Difference (RD) -6.4 (95% CI -21.0 to 8.1); Mixed Models Analysis NCT01490580 ↗
paper adjusted RD, -6.4; 95% CI, -21.0 to 8.1; P = .38 PMID 29715354 ↗
Publications
- Results Durrmeyer X, Breinig S, Claris O, Tourneux P, Alexandre C, Saliba E, Beuchee A, Jung C, Levy C, Marchand-Martin L, Marcoux MO, Dechartres A, Danan C; PRETTINEO Research Group. Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1790-1801. doi: 10.1001/jama.2018.3708.
- Results Tauzin M, Marchand-Martin L, Lebeaux C, Breinig S, Claris O, Tourneux P, Alexandre C, Levy C, Jung C, Dechartres A, Durrmeyer X; PREmedication Trial for Tracheal Intubation of the NEOnate Research Group. Neurodevelopmental Outcomes after Premedication with Atropine/Propofol vs Atropine/Atracurium/Sufentanil for Neonatal Intubation: 2-Year Follow-Up of a Randomized Clinical Trial. J Pediatr. 2021 Apr;231:273-277.e3. doi: 10.1016/j.jpeds.2020.12.001. Epub 2020 Dec 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atracurium | Small molecule | 0.3 mg/kg | — |
| Subject | Propofol | Small molecule | 1 mg/kg | Other |
| Subject | Propofol | Small molecule | 2.5 mg/kg | Other |
| Comparator | Sufentanil | Other / unclassified | 0.1 ug/kg | — |
| Comparator | Sufentanil | Other / unclassified | 0.2 ug/kg | — |
| Background | Atropine | Other / unclassified | 20 ug/kg | — |
Indications
No indication recorded.