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. 2020 Aug;40(8):1193-1201.
doi: 10.1038/s41372-020-0690-5. Epub 2020 May 20.

A trial comparing continuous positive airway pressure (CPAP) devices in preterm infants

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

A trial comparing continuous positive airway pressure (CPAP) devices in preterm infants

Carl H Backes et al. J Perinatol. 2020 Aug.

Abstract

Objective: To test the hypothesis that infants born <30 weeks' gestation supported by Seattle-PAP will have lower rates of continuous positive airway pressure (CPAP) failure than infants supported with conventional, Fisher&Paykel-CPAP (FP-CPAP).

Study design: Randomized trial (3/2017-01/2019) at 5 NICUs. The primary outcome was CPAP failure; subgroup analyses (gestational age, receipt antenatal corticosteroids) were performed.

Results: A total of 232 infants were randomized. Infants in the Seattle-PAP and FP-CPAP groups had mean gestational ages of 27.0 and 27.2 weeks, respectively. We observed no differences in rates of treatment failure between Seattle-PAP (40/112, 35.7%) and FP-CPAP (38/120, 31.7%; risk difference, 4.1%; 95% CI, -8.1-16.2; P = 0.51). Subgroup analysis indicated no differences in rates of CPAP failure. We observed no differences between the two groups in frequencies of adverse events or duration of respiratory support.

Conclusions: Among infants born <30 weeks' gestation, rates of CPAP failure did not differ between Seattle-PAP and FP-CPAP.

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Conflict of interest statement

CPR, 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”. 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 rights to the Seattle-PAP device have been licensed to Draeger, Inc. CHB is a consultant for Abbott. The remaining authors have no other interests to declare.

Figures

Fig. 1
Fig. 1. Illustration of Fisher & Paykel (left) and Seattle-PAP (right) bubble CPAP generators.
The expiratory limb of the circuit is oriented vertically into the water seal of the bubbler apparatus (0°) in Fisher & Paykel, while the expiratory limb of the circuit in Seattle-PAP is maintained at 135°.
Fig. 2
Fig. 2. Screening, randomization, and study completion.
From March 24th, 2017 to January 5th, 2019, a total of five NICUs screened 330 infants who met the inclusion criteria, of whom 309 were eligible and 21 were excluded. The caregivers of 25 infants were not approached for informed consent, the caregivers of 46 did not provide consent, and six caregivers provided consent, but the infant did not undergo randomization after failing to extubate within 72 h of life. A total of 232 infants were randomized and enrolled. CPAP denotes continuous positive airway pressure.
See this image and copyright information in PMC

References

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