Document Type
Article
Publication Title
Trials
Abstract
BACKGROUND: At birth, the majority of neonates born at < 30 weeks of gestation require respiratory support to facilitate transition and ensure adequate gas exchange. Although the optimal approach to the initial respiratory management is uncertain, the American Academy of Pediatrics endorses noninvasive respiratory support with nasal continuous positive airway pressure (nCPAP) for premature neonates with respiratory insufficiency. Despite evidence for its use, nCPAP failure, requiring intubation and mechanical ventilation, is common. Recently, investigators have described a novel method to deliver bubble nCPAP, termed Seattle-PAP. While preclinical and pilot studies are encouraging regarding the potential value of Seattle-PAP, a large trial is needed to compare Seattle-PAP directly with the current standard of care for bubble nCPAP (Fisher & Paykel CPAP or FP-CPAP).
METHODS/DESIGN: We designed a multicenter, non-blinded, randomized controlled trial that will enroll 230 premature infants (22
DISCUSSION: This trial will assess whether Seattle-PAP is more efficacious and cost-effective than FP-CPAP in real-world practice among premature neonates.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT03085329 . Registered on 21 March 2017.
First Page
63
Last Page
63
DOI
10.1186/s13063-018-3166-6
Publication Date
1-18-2019
Recommended Citation
Backes CH, Notestine JL, Lamp JM, Balough JC, Notestine AM, Alfred CM, Kern JM, Stenger MR, Rivera BK, Moallem M, Miller RR, Naik A, Cooper JN, Howard CR, Welty SE, Hillman NH, Zupancic JAF, Stanberry LI, Hansen TN, Smith CV. Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial. Trials. 2019 Jan 18;20(1):63. doi: 10.1186/s13063-018-3166-6. PMID: 30658678; PMCID: PMC6339409.