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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome; Infant, Premature
• Interventions: Device: bCPAP with blenders

• Registration Number: NCT05462509
• Lead Sponsor: PATH

Brief 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.

Study Timeline

• Study Start: 2021-10-04
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15
• Study First Submitted: 2022-06-16
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-18
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bCPAP and blenders	bCPAP with blenders	all patients admitted to the newborn care unit with respiratory failure will be evaluated for treatment with bCPAP per unit standards. All patients that meet treatment criteria will receive bCPAP. Patients for whom consent is available will be enrolled and start bCPAP therapy with the PATH kit. Patients for whom consent is not given or not available will start Kiwoko bCPAP. Patients who began bCPAP therapy with the Kiwoko kit and obtain consent within 24 hours of starting their bCPAP therapy may switch from Kiwoko to PATH bCPAP. Patients with \>24 hours of Kiwoko bCPAP therapy are no longer eligible for enrolment. , oxygen blending for patients treated with PATH bCPAP will occur by the following two methods- and will be used in this order of preference: 1. blending via air compressor (standard of care in unit and used when available) 2. blending via PATH blender (when no compressor available)

Primary Outcome Measures

Name	Time	Method
Usability of the bCPAP device	Immediately after use of the device	Median time of device set up in minutes
Usability of the blenders device	Immediately after use of the device	Median time of changing blender in seconds
Acceptability of the bCPAP and blenders device	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 Outcome Measures

Name	Time	Method
Outcomes of patients treated: treatment length	Immediately at end of bCPAP therapy	Median treatment length in days
Demographics of patients treated	At enrollment	Place of birth, sex, median weeks gestation
Clinical characteristics of patients treated: median admission weight	At enrollment	Median admission weight in kg
Clinical characteristics of patients treated: reason for admission	At enrollment	Reason for admission
Outcomes of patients treated: patient age	At baseline	Age (in weeks) when bCPAP therapy started
Outcomes of patients treated: device pressure	Immediately at end of bCPAP therapy	Median pressure (in cmH2O) used during treatment
Outcomes of patients treated: device flow	Immediately at end of bCPAP therapy	Median oxygen source flow (in LPM) used during treatment

Trial Locations

Locations (1)

Kiwoko Hospital; 🇺🇬 Kiwoko, Nakaseke, Uganda