NCT05462509

Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda

Feasibility of Use of the PATH bCPAP Kit Including Oxygen Blenders in a Neonatal Population in Uganda

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 24 Weeks – 44 Weeks
• Healthy volunteers: Not accepted

Summary

In this mixed methods study, the investigators assessed feasibility of use of the PATH bCPAP kit on neonatal patients as well as the usability and acceptability of the device by healthcare workers.The study took place in a rural Ugandan special care nursery with experience in bCPAP. Neonates with respiratory failure were consented and treated with the PATH bCPAP kit and blenders. The investigators conducted prospective data collection of the device use through observation as well as collected qualitative data via interviews with nurses, which were analyzed using a rapid qualitative analytical method.

Detailed description

Preterm birth is responsible for 1/3 of deaths under age five- the majority which occur in resource-constrained settings. Many of these deaths are due to respiratory failure which can be treated with bubble continuous positive airway pressure (bCPAP). Commercialized bCPAP devices are expensive, leading resource-constrained settings to make and use improvised devices. These improvised devices have not been tested for performance and run on 100% oxygen. WHO guidelines strongly advise against the use of 100% oxygen-particularly with preterm newborns where it can cause blindness, lung and brain injury. To address this need, PATH has developed a low-cost bCPAP kit which includes oxygen blenders that do not require electricity nor a source of pressurized air to blend oxygen with air. The objectives of this early feasibility study are to: 1. assess the operational feasibility of using the PATH bCPAP kit including, when appropriate, in-line oxygen blending on neonatal patients and 2. assess the usability and acceptability of the PATH bCPAP kit with oxygen blenders by healthcare workers. Newborns will be treated with the PATH bCPAP kit and a subset of these will also be treated with the PATH blender as needed to provide blended oxygen. Results from this study will be used to identify appropriate modification to the use procedures and/or the device as needed. Once testing is completed and product revision finalized, the PATH kit and blenders will allow resource-constrained settings to provide rigorously tested bCPAP therapy and blended oxygen to patients with reduced risk of morbidity from oxygen toxicity.

Conditions

• Respiratory Distress Syndrome
• Infant, Premature

Interventions

Type	Name	Description
DEVICE	bCPAP with blenders	The intervention device is a low-cost bCPAP kit which includes two fixed-ratio oxygen blenders that do not require a source of pressurized air. These simple and inexpensive devices sit in-line from the oxygen source and dilute the flowing stream of oxygen with room air, obviating the need for a pressurized source of air. The oxygen may be supplied from either high-pressure sources or low-pressure sources such as oxygen concentrators. Each of the two blenders are single plastic parts, injection moulded from a biocompatible, medical-grade polyethylene resin. No electricity is required for the blenders to provide a stable and constant mix of air and oxygen over the full range of clinically relevant pressure and flows for newborns.

Timeline

• Start date: 2021-10-04
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2022-07-18
• Last updated: 2023-04-18

Locations

1 site across 1 country: Uganda