Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda
Condition: Respiratory Distress Syndrome; Infant, Premature
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

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.
    

Intervention name(s): bCPAP with blenders
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research