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

NCT05462509 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-04-18

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome
  • Infant, Premature

Interventions

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.

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • Adara Development

    collaborator UNKNOWN

  • Kiwoko Hospital

    collaborator UNKNOWN

  • PATH

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Weeks
Max Age
44 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2021-12-15
Completion
2021-12-15

Countries

  • Uganda

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05462509 on ClinicalTrials.gov