Infant, Premature, Respiratory Distress Syndrome
Conditions
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.
Interventions
DEVICEbCPAP 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.
Sponsors
University of Washington
Adara Development
Kiwoko Hospital
PATH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 44 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Demographics of patients treated | At enrollment | Place of birth, sex, median weeks gestation |
| Outcomes of patients treated: treatment length | Immediately at end of bCPAP therapy | Median treatment length in days |
| Outcomes of patients treated: device flow | Immediately at end of bCPAP therapy | Median oxygen source flow (in LPM) used during treatment |
| 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 |
Countries
Uganda
Outcome results
None listed