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. 2019 Jan 18;20(1):63.
doi: 10.1186/s13063-018-3166-6.

Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial

Carl H Backes  1   2   3 , Jennifer L Notestine  4 , Jane M Lamp  5 , Jeanne C Balough  4 , Allison M Notestine  4 , Crystal M Alfred  6 , Juli M Kern  7 , Michael R Stenger  6 , Brian K Rivera  4 , Mohannad Moallem  6 , Randy R Miller  7   8 , Apurwa Naik  9 , Jennifer N Cooper  6   10   11 , Christopher R Howard  12 , Stephen E Welty  12   13 , Noah H Hillman  14 , John A F Zupancic  15   16 , Larissa I Stanberry  17 , Thomas N Hansen  12 , Charles V Smith  12
Affiliations

Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial

Carl H Backes et al. 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 (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: ClinicalTrials.gov, NCT03085329 . Registered on 21 March 2017.

Keywords: Continuous positive airway pressure (CPAP); Costs; Costs analysis; Infant; Neonate; Preterm Infant; Randomized controlled trial.

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Conflict of interest statement

Ethics approval and consent to participate

The IRB of NCH approved the trial (16–00678). The IRB at Mt. Carmel St. Ann’s Hospital granted separate approval for the trial (170817–2).

Consent for publication

Not applicable.

Competing interests

TNH and CVS are included among the holders of patents on the Seattle-PAP device, specifically United States Patent 8499759, under the title “Broad-band, low frequency, high-amplitude, long time duration, oscillating airway pressure breathing apparatus and method utilizing bubbles.” This listing is readily available on-line. The patent is also registered with the World Intellectual Property Organization (PCT/US2009/039957), with patents or letters granted in several regions or countries, including Europe (2303373), Korea (10–1,540,948), New Zealand (588682), China (201310269076.X), Canada (2720976), Vietnam (13756), and India (7898/DELNP/2010). A patent has also been issued in Australia (2010241205) under a modified name. The patent holders are committed to the Global Access Policy (http://globalaccess.gatesfoundation.org) of the Bill & Melinda Gates Foundation. The rights to the Seattle-PAP device have been licensed to Draeger, which will have no role in the study. The remaining authors have no potentially competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schematic showing the primary components of a bubble nCPAP circuit. The differences in conventional and Seattle-PAP bubbler devices are shown. All other elements of the CPAP circuit are identical between the groups
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments during the study
Fig. 3
Fig. 3
Study flow chart. bn-CPAP bubble nasal continuous positive airway pressure, CGA corrected gestational age
See this image and copyright information in PMC

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