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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.

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 0/7 to 29 6/7 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.

Background: Almost one million prematurely born infants die annually from respiratory insufficiency, predominantly in countries with limited access to respiratory support for neonates. The primary hypothesis tested in the present study was that a modified device for bubble nasal continuous positive airway pressure (Bn-CPAP) would provide lower work of spontaneous breathing, estimated by esophageal pressure-rate products., Methods: Infants born <32 weeks gestation and stable on Bn-CPAP with FiO2 <0.30 were studied within 72 h following delivery. Esophageal pressures during spontaneous breathing were measured during 2 h on standard Bn-CPAP, then 2 h with Bn-CPAP using a modified bubble device presently termed Seattle-PAP, which produces a different pattern of pressure fluctuations and which provided greater respiratory support in preclinical studies, then 2 h on standard Bn-CPAP., Results: All 40 infants enrolled completed the study and follow-up through 36 wks post menstrual age or hospital discharge, whichever came first. No infants were on supplemental oxygen at completion of follow-up. No infants developed pneumothoraces or nasal trauma, and no adverse events attributed to the study were observed. Pressure-rate products on the two devices were not different, but effort of breathing, assessed by areas under esophageal pressure-time curves, was lower with Seattle-PAP than with standard Bn-CPAP., Conclusion: Use of Seattle-PAP to implement Bn-CPAP lowers the effort of breathing exerted even by relatively healthy spontaneously breathing premature neonates. Whether the lower effort of breathing observed with Seattle-PAP translates to improvements in neonatal mortality or morbidity will need to be determined by studies in appropriate patient populations.

Background: High-flow nasal cannula (HFNC) is a well-established respiratory support device in high-income countries, but to our knowledge, its use in sub-Saharan Africa has not been reported. This feasability study describes the implementation process of HFNC in rural Kenya. Methods: HFNC was implemented in intensive care and high dependency units at Kijabe Hospital, Kenya for children with acute lower respiratory disease. Rate of intubation was compared with historical controls and challenges of implementation described. Results: Fifteen patients received HFNC between January and November 2016, and compared to 25 historical control patients. Both groups had many comorbidities, and control patients were significantly younger. There were no significant differences in clinical outcome between the groups: 5 (33%) HFNC vs 12 (48%) controls required intubation; 10 (67%) HFNC vs 22 (88%) controls survived to discharge; and the HFNC required 3 vs the controls' 4 days on respiratory support. The greatest technical issues encountered were large pressure differences between air from a wall outlet (wall air) and oxygen and an inability to automatically refill humidifier water chambers. Conclusion: HFNC in limited-resource settings is feasible but there were technical challenges and concern about the increased workload. The small sample size, heterogeneous population, availability of oxygen and blending of wall air at the study site limit inferences for other sites in low- and middle-income countries. Abbreviations: ALRI, acute lower respiratory infection; CPAP, continuous positive airway pressure; ETAT, emergency triage, assessment and treatment; HDU, high dependency unit; HFNC, high-flow nasal cannula; HIC, high-income country; HR, heart rate; ICU, intensive care unit; LMIC, low- and middle-income countries; PSI, pounds per square inch; RR, respiratory rate; mRISC, modified Respiratory Index of Severity in Children. [ABSTRACT FROM AUTHOR]