Summary: | <h4>Background</h4>Preterm birth and resulting respiratory failure is a leading cause of newborn death- the majority of which occur in resource-constrained settings and could be prevented with bubble continuous positive airway pressure (bCPAP). Commercialized devices are expensive, however, and sites commonly use improvised devices utilizing 100% oxygen which can cause blindness. To address this, PATH and a multidisciplinary team developed a very low-cost bCPAP device including fixed-ratio oxygen blenders.<h4>Objective</h4>We assessed feasibility of use of the device on neonatal patients as well as the usability and acceptability of the device by healthcare workers. This study did not evaluate device effectiveness.<h4>Methods</h4>The study took place in a Ugandan level two unit. Neonates with respiratory failure were treated with the bCPAP device. Prospective data were collected through observation as well as likert-style scales and interviews with healthcare workers. Data were analyzed using frequencies, means and standard deviation and interviews via a descriptive coding method. Retrospectively registered via ClinicalTrials.gov number NCT05462509.<h4>Results</h4>Fourteen neonates were treated with the bCPAP device in October-December 2021. Patients were born onsite (57%), with median weight of 1.3 kg (IQR 1-1.8). Median treatment length was 2.5 days (IQR 2-6). bCPAP was stopped due to: improvement (83%) and death (17%). All patients experienced episodes of saturations >95%. Median time for device set up: 15 minutes (IQR 12-18) and changing the blender: 15 seconds (IQR 12-27). After initial device use, 9 out of 9 nurses report the set-up as well as blender use was "easy" and their overall satisfaction with the device was 8.5/10 (IQR 6.5-9.5). Interview themes included the appreciation for the ability to administer less than 100% oxygen, desire to continue use of the device, and a desire for additional blenders.<h4>Conclusions</h4>In facilities otherwise using 100% oxygen, use of the bCPAP device including oxygen blenders is feasible and acceptable to healthcare workers.<h4>Trial registration</h4>ClinicalTrials.gov, Identifier NCT05462509.
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