PrematurePhase 2NCT06082674
Novel Low Cost Bubble CPAP as an Alternative Respiratory Support in Low Resource Setting
A Phase 2 study testing Vayu bCPAP and Mechanical Ventilator Driven CPAP in people with Premature and Respiratory Distress Syndrome in Premature Infant, run by Ilocos Training and Regional Medical Center at 1 site in Philippines.
Trial summary
This is a single-blind randomized controlled trial done in a Level III neonatal intensive care unit. Preterm newborns with RDS were randomized to receive oxygen therapy through bubble CPAP vs ventilator-derived CPAP. Read more about this study
- Who is it for?
- Ages 5 minutes to 6 hours
- Conditions the study is for
- Premature, Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- Vayu bCPAP and Mechanical Ventilator Driven CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Apr 2022to 1 Dec 2022
- Phase
- Phase 2
- 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 5 minutes to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Included are preterm neonates less than 36 weeks (WHO definition)
- admitted at NICU
- APGAR scores of > 7 in the 1st and 5th minute of life
- in respiratory distress at birth,
- radiologic findings of RDS
- Respiratory Severity Score (RSS) or Downe's score > 4 at 10-15 minutes after hooking to CPAP
- requiring CPAP or more than 40% FiO2
Who cannot join
- Infants requiring neonatal resuscitation such as bag mask ventilation, chest compression or intubation at birth
- with comorbidities such as facial anomalies, tracheoesophageal fistulas, congenital heart disease, and other congenital anomalies which may interfere with the interface of both devices.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Ilocos Training and Regional Medical Center
San Fernando City, La Union, 2500
About this study
Official title: Novel Low Cost Bubble CPAP as an Alternative Non-invasive Respiratory Support Among Preterm Infants With Respiratory Distress Syndrome
This is a single-blind randomized controlled trial done in a Level III neonatal intensive care unit. Preterm newborns with RDS were randomized to receive oxygen therapy through bubble CPAP vs ventilator-derived CPAP. Differences in arterial blood gases, oxygen saturation, number of surfactant and CPAP failure rate between study groups were analyzed.
Read the detailed description
Background and Objective: Respiratory distress syndrome (RDS) among premature infants is one of the major causes of neonatal death. The use of continuous positive airway pressure (CPAP) has become a standard of care for preterm newborns with RDS. In countries faced with the challenge of improving neonatal care, cost-effective innovations for respiratory support are a promising intervention. This study determined the efficacy of a low-cost bubble CPAP as an alternative non-invasive oxygen therapy for newborn infants with RDS.
METHODS: This is a single-blind randomized controlled trial done in a Level III neonatal intensive care unit. Preterm newborns with RDS were randomized to receive oxygen therapy through bubble CPAP vs ventilator-derived CPAP. Differences in arterial blood gases, oxygen saturation, number of surfactant and CPAP failure rate between study groups were analyzed.
- Being tested
- Vayu bCPAP, Mechanical Ventilator Driven CPAP
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vayu bCPAPDevice
The Vayu bCPAP uses a constant flow of dry oxygen from the source with an adjustable flow meter. Oxygen is blended by Venturi blender with ambient air to create a source of oxygen-enriched air of adjustable concentration.
Mechanical Ventilator Driven CPAPDevice
Mechanical Ventilator Driven CPAP
| Study group | Role | What they receive |
|---|---|---|
| Vayu CPAP Group | Experimental | The patients will be hooked to VAYu bCPAP Receives: Device: Vayu bCPAP |
| Mechanical Ventilator Driven CPAP | Active comparator | Patients will be hooked to Mechanical Ventilator Driven CPAP Receives: Device: Mechanical Ventilator Driven CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas
Difference in the Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas
Measured: 8 months
Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
Difference in the Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
Measured: 8 months
Oxygen Saturation
Difference in the oxygen saturation using pulse oximeter
Measured: 8 months
Secondary outcomes (2)
CPAP Failure
Difference in the number of CPAP failure
Measured: 8 months
surfactant use
total number of surfactant use
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Apr 2022
- Primary completion15 Nov 2022
- Study completion1 Dec 2022
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 PrematureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilocos Training and Regional Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Navid Roodaki, Ilocos Training and Regional Medical Center
- Investigators
- Navid Roodaki, MD, Principal investigator, Ilocos Training and Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082674
- Sponsor's protocol ID
- ITRMC-REC-2022-11
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Badin S, Roodaki N, Garcia DEC, Abila-Cariaga R, Burke TF. Evaluation of a novel reprocessed bCPAP system on sepsis rates among preterm neonates with respiratory distress: a randomized controlled trial. Front Pediatr. 2025 May 19;13:1569437. doi: 10.3389/fped.2025.1569437. eCollection 2025.
PubMed 40458453
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Low Cost Bubble CPAP as an Alternative Non-invasive Respiratory Support Among Preterm Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06082674
- Acronym / sponsor ID
- ITRMC-REC-2022-11
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ilocos Training and Regional Medical CenterOther government
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 13 Oct 2023 (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.
This is a single-blind randomized controlled trial done in a Level III neonatal intensive care unit. Preterm newborns with RDS were randomized to receive oxygen therapy through bubble CPAP vs ventilator-derived CPAP. Differences in arterial blood gases, oxygen saturation, number of surfactant and CPAP failure rate between study groups were analyzed.
Detailed description
Background and Objective: Respiratory distress syndrome (RDS) among premature infants is one of the major causes of neonatal death. The use of continuous positive airway pressure (CPAP) has become a standard of care for preterm newborns with RDS. In countries faced with the challenge of improving neonatal care, cost-effective innovations for respiratory support are a promising intervention. This study determined the efficacy of a low-cost bubble CPAP as an alternative non-invasive oxygen therapy for newborn infants with RDS.
METHODS: This is a single-blind randomized controlled trial done in a Level III neonatal intensive care unit. Preterm newborns with RDS were randomized to receive oxygen therapy through bubble CPAP vs ventilator-derived CPAP. Differences in arterial blood gases, oxygen saturation, number of surfactant and CPAP failure rate between study groups were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vayu CPAP Group | Experimental | Device: Vayu bCPAPThe patients will be hooked to VAYu bCPAP |
| Mechanical Ventilator Driven CPAP | Active comparator | Device: Mechanical Ventilator Driven CPAPPatients will be hooked to Mechanical Ventilator Driven CPAP |
Who may qualify
- Ages
- 5 minutes to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Included are preterm neonates less than 36 weeks (WHO definition)
- admitted at NICU
- APGAR scores of > 7 in the 1st and 5th minute of life
- in respiratory distress at birth,
- radiologic findings of RDS
Key exclusion criteria (2 listed)
- Infants requiring neonatal resuscitation such as bag mask ventilation, chest compression or intubation at birth
- with comorbidities such as facial anomalies, tracheoesophageal fistulas, congenital heart disease, and other congenital anomalies which may interfere with the interface of both devices.
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 |
|---|---|---|
| Vayu bCPAPThe Vayu bCPAP uses a constant flow of dry oxygen from the source with an adjustable flow meter. Oxygen is blended by Venturi blender with ambient air to create a source of oxygen-enriched air of adjustable concentration. | Device | Vayu CPAP Group |
| Mechanical Ventilator Driven CPAPMechanical Ventilator Driven CPAP | Device | Mechanical Ventilator Driven CPAP |
Primary outcome
Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas
Time frame: 8 months
Difference in the Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas
Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
Time frame: 8 months
Difference in the Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
Oxygen Saturation
Time frame: 8 months
Difference in the oxygen saturation using pulse oximeter
2 secondary outcomes
CPAP Failure
Time frame: 8 months
surfactant use
Time frame: 8 months
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 13 Oct 2023.
- Derived from this study: PubMed 40458453Badin S, Roodaki N, Garcia DEC, Abila-Cariaga R, Burke TF. Evaluation of a novel reprocessed bCPAP system on sepsis rates among preterm neonates with respiratory distress: a randomized controlled trial. Front Pediatr. 2025 May 19;13:1569437. doi: 10.3389/fped.2025.1569437. eCollection 2025.
- 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.
Navid Roodaki, MD principal investigator
Ilocos Training and Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vayu bCPAP and Mechanical Ventilator Driven CPAP in people with Premature and Respiratory Distress Syndrome in Premature Infant, run by Ilocos Training and Regional Medical Center at 1 site in Philippines.
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 7 inclusion and 2 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 13 Oct 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 Philippines. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas (time frame: 8 months). 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 NCT06082674, 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 13 Oct 2023.