Feasibility and usability of a very low-cost bubble continuous positive airway pressure device including oxygen blenders in a Ugandan level two newborn unit

Anna B Hedstrom; James Nyonyintono; Eugene A Saxon; Heidi Nakamura; Hilda Namakula; Beatrice Niyonshaba; Josephine Nakakande; Noelle Simpson; Madeline Vaughan; Alec Wollen; Paul Mubiri; Peter Waiswa; Patricia S Coffey; Maneesh Batra

doi:10.1371/journal.pgph.0001354

Feasibility and usability of a very low-cost bubble continuous positive airway pressure device including oxygen blenders in a Ugandan level two newborn unit

PLOS Glob Public Health. 2023 Mar 8;3(3):e0001354. doi: 10.1371/journal.pgph.0001354. eCollection 2023.

Authors

Affiliations

¹ Department of Pediatrics and Global Health, University of Washington, Seattle, Washington, United States of America.
² Kiwoko Hospital, Kiwoko, Uganda.
³ EPFL EssentialTech Centre, the Swiss Federal Institute of Technology, Lausanne, Switzerland.
⁴ Adara Development, Sydney, Australia.
⁵ Medical Devices and Health Technologies, PATH, Seattle, Washington, United States of America.
⁶ Department of Health Policy, Planning and Management, Makerere University, Kampala, Uganda.

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: In facilities otherwise using 100% oxygen, use of the bCPAP device including oxygen blenders is feasible and acceptable to healthcare workers.

Trial registration: ClinicalTrials.gov, Identifier NCT05462509.

Copyright: © 2023 Hedstrom et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Associated data

ClinicalTrials.gov/NCT05462509

Grants and funding

Funding provided by Saving Lives at Birth (https://savinglivesatbirth.net/) Awd #1802-32086 to PATH. Initials of the authors who were funded under this award: AH, JN, HNakamura, HNamakula, BN, JN, AW, PM, PSC. This project is made possible through the generous support of the Saving Lives at Birth partners: the United States Agency for International Development (USAID), the Norwegian Agency for Development Cooperation (Norad), the Bill & Melinda Gates Foundation, Grand Challenges Canada, the U.K. Department for International Development (DFID), and the Korea International Cooperation Agency (KOICA). This manuscript was prepared by the University of Washington, Adara Development, Kiwoko Hospital, PATH and Makerere University and does not necessarily reflect the views of the Saving Lives at Birth partners. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.