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NCT Number: NCT05462509

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

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.

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Key information

Conditions

Respiratory Distress Syndrome Female Urogenital Diseases and Pregnancy Complications Infant, Premature Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Urogenital Diseases

Age range

24 week–44 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kiwoko Hospital

Kiwoko, Nakaseke, Uganda

About this study

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:

  • assess the operational feasibility of using the PATH bCPAP kit including, when appropriate, in-line oxygen blending on neonatal patients and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborns <44 weeks post menstrual age with respiratory failure requiring treatment with bCPAP therapy during the period of study
  • Parent or legal guardian consented to participation in the study within 24 hours of bCPAP initiation.

Exclusion criteria

  • No parental nor legal guardian consent for participation in the study.

Treatment and study plan

bCPAP with blenders

Device

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.

Primary outcomes

  1. Usability of the bCPAP device

    Time frame: Immediately after use of the device

    Median time of device set up in minutes

  2. Usability of the blenders device

    Time frame: Immediately after use of the device

    Median time of changing blender in seconds

  3. Acceptability of the bCPAP and blenders device

    Time frame: Within the first five days of having used the device for the first time

    Median score on Likert-type scale (rating of 1-10 with 10 being best) for health worker satisfaction with device

Secondary outcomes

  1. Demographics of patients treated

    Time frame: At enrollment

    Place of birth, sex, median weeks gestation

  2. Clinical characteristics of patients treated: median admission weight

    Time frame: At enrollment

    Median admission weight in kg

  3. Clinical characteristics of patients treated: reason for admission

    Time frame: At enrollment

    Reason for admission

  4. Outcomes of patients treated: patient age

    Time frame: At baseline

    Age (in weeks) when bCPAP therapy started

  5. Outcomes of patients treated: device pressure

    Time frame: Immediately at end of bCPAP therapy

    Median pressure (in cmH2O) used during treatment

  6. Outcomes of patients treated: device flow

    Time frame: Immediately at end of bCPAP therapy

    Median oxygen source flow (in LPM) used during treatment

  7. Outcomes of patients treated: treatment length

    Time frame: Immediately at end of bCPAP therapy

    Median treatment length in days

Sponsors and collaborators

Lead sponsor

PATH

Other

Collaborators

  • Adara Development
  • Kiwoko Hospital
  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 18, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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