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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome; Infant, Premature
• Intervention / Treatment: Device: bCPAP with blenders

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Nakaseke
    • Kiwoko, Nakaseke, Uganda
      • Kiwoko Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: bCPAP and 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: blending via air compressor (standard of care in unit and used when available); blending via PATH blender (when no compressor available)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Usability of the bCPAP device	Median time of device set up in minutes	Immediately after use of the device
Usability of the blenders device	Median time of changing blender in seconds	Immediately after use of the device

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PATH
• Collaborators: University of Washington; Adara Development; Kiwoko Hospital

Publications and helpful links

General Publications

• Wang G, Li L, Wang J, Zang J, Chen J, Xiao Y, Fan X, Zhu L, Kung HF, Zhu Z. Head-to-head comparison of [68Ga]Ga-P16-093 and 2-[18F]FDG PET/CT in patients with clear cell renal cell carcinoma: a pilot study. Eur J Nucl Med Mol Imaging. 2023 Apr;50(5):1499-1509. doi: 10.1007/s00259-022-06101-3. Epub 2023 Jan 5.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 1519912-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No