drugset / Trial / NCT01116921
Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive surfactant.
Timeline
- Start
- 2011-02
- Primary completion
- 2015-04
- Completion
- 2015-04
Outcome
Met primary endpoint
paper Surfactant administration through an LMA (n = 50) significantly decreased the rate of intubation and mechanical ventilation compared with controls (n = 53) PMID 29174079 ↗
paper 38% vs 64%, respectively, OR 0.30 (95% CI 0.13, 0.70), P = .006 PMID 29174079 ↗
Publications
- Wanous AA, Brown R, Rudser KD, Roberts KD. Comparison of laryngeal mask airway and endotracheal tube placement in neonates. J Perinatol. 2024 Feb;44(2):239-243. doi: 10.1038/s41372-023-01818-x. Epub 2023 Nov 2.
- Roberts K, Wanous A, Brown R, Rudser K. Comparison of Laryngeal Mask Airway and Endotracheal Tube Placement in Neonates. Res Sq [Preprint]. 2023 Jul 13:rs.3.rs-3136331. doi: 10.21203/rs.3.rs-3136331/v1.
- Roberts KD, Brown R, Lampland AL, Leone TA, Rudser KD, Finer NN, Rich WD, Merritt TA, Czynski AJ, Kessel JM, Tipnis SM, Stepka EC, Mammel MC. Laryngeal Mask Airway for Surfactant Administration in Neonates: A Randomized, Controlled Trial. J Pediatr. 2018 Feb;193:40-46.e1. doi: 10.1016/j.jpeds.2017.09.068. Epub 2017 Nov 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Poractant alfa | Other / unclassified | 2.5 unknown | Other |