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

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05462509
• Other study ID #: 1519912-11
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: July 2022
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 44 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Infant, Premature
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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.

Locations

Country	Name	City	State
Uganda	Kiwoko Hospital	Kiwoko	Nakaseke

Sponsors (4)

Lead Sponsor	Collaborator
PATH	Adara Development, Kiwoko Hospital, University of Washington

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability of the bCPAP device	Median time of device set up in minutes	Immediately after use of the device
Primary	Usability of the blenders device	Median time of changing blender in seconds	Immediately after use of the device
Primary	Acceptability of the bCPAP and blenders device	Median score on Likert-type scale (rating of 1-10 with 10 being best) for health worker satisfaction with device	Within the first five days of having used the device for the first time
Secondary	Demographics of patients treated	Place of birth, sex, median weeks gestation	At enrollment
Secondary	Clinical characteristics of patients treated: median admission weight	Median admission weight in kg	At enrollment
Secondary	Clinical characteristics of patients treated: reason for admission	Reason for admission	At enrollment
Secondary	Outcomes of patients treated: patient age	Age (in weeks) when bCPAP therapy started	At baseline
Secondary	Outcomes of patients treated: device pressure	Median pressure (in cmH2O) used during treatment	Immediately at end of bCPAP therapy
Secondary	Outcomes of patients treated: device flow	Median oxygen source flow (in LPM) used during treatment	Immediately at end of bCPAP therapy
Secondary	Outcomes of patients treated: treatment length	Median treatment length in days	Immediately at end of bCPAP therapy