Evaluating the Efficacy of Seattle-PAP for the Respiratory Support of Premature Neonates: Study Protocol for a Randomized Controlled Trial

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 with regard to 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; FP-CPAP). Methods: We designed a multicenter, non-blinded, randomized controlled trial that will enroll 230 premature infants (220/7 to 296/7 weeks of gestation). Infants will be randomized to receive Seattle-PAP or FP-CPAP. The primary outcome is respiratory failure requiring intubation and mechanical ventilation. Secondary outcomes include measures of short and long-term respiratory morbidity and cost effectiveness. 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: This trial has been registered with the United States National Library of Medicine (www.clinicaltrials.gov, Trial Identifier #NCT03085329). Registered on 21 March 2017.