Clinical trial NCT05462509: Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda
Official title: Feasibility of Use of the PATH bCPAP Kit Including Oxygen Blenders in a Neonatal Population in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Infant, Premature
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Adara Development
name: Kiwoko Hospital
First posted: 2022-07-18
Enrollment: 14
Sex: ALL
Minimum age (years): 24
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Usability of the bCPAP device
timeFrame: Immediately after use of the device
measure: Usability of the blenders device
timeFrame: Immediately after use of the device
measure: Acceptability of the bCPAP and blenders device
timeFrame: Within the first five days of having used the device for the first time
Secondary outcomes:
measure: Demographics of patients treated
timeFrame: At enrollment
measure: Clinical characteristics of patients treated: median admission weight
timeFrame: At enrollment
measure: Clinical characteristics of patients treated: reason for admission
timeFrame: At enrollment
measure: Outcomes of patients treated: patient age
timeFrame: At baseline
measure: Outcomes of patients treated: device pressure
timeFrame: Immediately at end of bCPAP therapy
measure: Outcomes of patients treated: device flow
timeFrame: Immediately at end of bCPAP therapy
measure: Outcomes of patients treated: treatment length
timeFrame: Immediately at end of bCPAP therapy
Other outcomes:
Locations:
city: Kiwoko
country: Uganda
facility: Kiwoko Hospital
state: Nakaseke
Study officials:
References: