Respiratory Distress SyndromeNCT05462509
Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda
A study testing bCPAP with blenders in people with Respiratory Distress Syndrome and Infant, Premature, run by PATH at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 44 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Infant, Premature
- What is being tested?
- bCPAP with blenders
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUganda
- Study dates
- 4 Oct 2021to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 44 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- No parental nor legal guardian consent for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- assess the operational feasibility of using the PATH bCPAP kit including, when appropriate, in-line oxygen blending on neonatal patients and
- 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.
- Conditions
- Respiratory Distress Syndrome, Infant, Premature
- Being tested
- bCPAP with blenders
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bCPAP with blendersDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| bCPAP and blenders | Experimental | 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) Receives: Device: bCPAP with blenders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the bCPAP device
Median time of device set up in minutes
Measured: Immediately after use of the device
Usability of the blenders device
Median time of changing blender in seconds
Measured: Immediately after use of the device
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
Measured: Within the first five days of having used the device for the first time
Secondary outcomes (7)
Demographics of patients treated
Place of birth, sex, median weeks gestation
Measured: At enrollment
Clinical characteristics of patients treated: median admission weight
Median admission weight in kg
Measured: At enrollment
Clinical characteristics of patients treated: reason for admission
Reason for admission
Measured: At enrollment
Outcomes of patients treated: patient age
Age (in weeks) when bCPAP therapy started
Measured: At baseline
Outcomes of patients treated: device pressure
Median pressure (in cmH2O) used during treatment
Measured: Immediately at end of bCPAP therapy
Outcomes of patients treated: device flow
Median oxygen source flow (in LPM) used during treatment
Measured: Immediately at end of bCPAP therapy
Outcomes of patients treated: treatment length
Median treatment length in days
Measured: Immediately at end of bCPAP therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start4 Oct 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Adara Development, Kiwoko Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462509
- Sponsor's protocol ID
- 1519912-11
- Status last verified
- Jul 2022
- First submitted
- 16 Jun 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hedstrom AB, Nyonyintono J, Saxon EA, Nakamura H, Namakula H, Niyonshaba B, Nakakande J, Simpson N, Vaughan M, Wollen A, Mubiri P, Waiswa P, Coffey PS, Batra M. Feasibility and usability of a very low-cost bubble continuous positive airway pressure device including oxygen blenders in a Ugandan level two newborn unit. PLOS Glob Public Health. 2023 Mar 8;3(3):e0001354. doi: 10.1371/journal.pgph.0001354. eCollection 2023.
PubMed 36963078
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Use of the PATH bCPAP Kit Including Oxygen Blenders in a Neonatal Population in Uganda
- ClinicalTrials.gov ID
- NCT05462509
- Acronym / sponsor ID
- 1519912-11
- Conditions
- Respiratory Distress Syndrome, Infant, Premature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- University of Washington, Adara Development, Kiwoko Hospital
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- assess the operational feasibility of using the PATH bCPAP kit including, when appropriate, in-line oxygen blending on neonatal patients and
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bCPAP and blenders | Experimental | Device: bCPAP with blendersall 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) |
Who may qualify
- Ages
- 24 to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- No parental nor legal guardian consent for participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bCPAP with blendersThe 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. | Device | bCPAP and blenders |
Primary outcome
Usability of the bCPAP device
Time frame: Immediately after use of the device
Median time of device set up in minutes
Usability of the blenders device
Time frame: Immediately after use of the device
Median time of changing blender in seconds
Acceptability of the bCPAP and blenders device
Time frame: 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
7 secondary outcomes
Demographics of patients treated
Time frame: At enrollment
Clinical characteristics of patients treated: median admission weight
Time frame: At enrollment
Clinical characteristics of patients treated: reason for admission
Time frame: At enrollment
Outcomes of patients treated: patient age
Time frame: At baseline
Outcomes of patients treated: device pressure
Time frame: Immediately at end of bCPAP therapy
Outcomes of patients treated: device flow
Time frame: Immediately at end of bCPAP therapy
Outcomes of patients treated: treatment length
Time frame: Immediately at end of bCPAP therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 36963078Hedstrom AB, Nyonyintono J, Saxon EA, Nakamura H, Namakula H, Niyonshaba B, Nakakande J, Simpson N, Vaughan M, Wollen A, Mubiri P, Waiswa P, Coffey PS, Batra M. Feasibility and usability of a very low-cost bubble continuous positive airway pressure device including oxygen blenders in a Ugandan level two newborn unit. PLOS Glob Public Health. 2023 Mar 8;3(3):e0001354. doi: 10.1371/journal.pgph.0001354. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bCPAP with blenders in people with Respiratory Distress Syndrome and Infant, Premature, run by PATH at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the bCPAP device (time frame: Immediately after use of the device). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05462509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.