Using bubble CPAP sounds to measure airway pressure in premature infants
Official title: The Use of Bubble Continuous Positive Airway Pressure in Premature Infants: Acoustics as a Metric of Effective Pressure Delivery
Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT07060833 · Data updated 2026-11-12
This project will try to see if the sounds made by bubble CPAP can tell us how much airway pressure very premature infants (born before 32 weeks) are actually receiving.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 28 Weeks to 32 Weeks |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Status | Recruiting |
| Started | April 3, 2025 |
| Main results expected | September 2026 |
| Study ends | December 2026 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT07060833 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are preterm infants on binasal bubble CPAP (5–7 cm H2O, flow 6–10 L/min), born before 32+0 weeks gestation, older than 7 days postnatal, and between 28+0 and 36+6 weeks postmenstrual age who are clinically stable.
✕Probably not a fit
Infants who are clinically unstable or excluded by protocol—such as those with major congenital or cardiac anomalies, neuromuscular disease, on ventilator-derived CPAP or nasal mask interfaces, or receiving inotropes, sedatives, or narcotics—are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will recruit 30 preterm infants born before 32+0 weeks who are receiving binasal bubble CPAP in the McGill NICU and record ambient and transmitted bubbling sounds alongside simultaneous pressure measurements using internal and external pressure transducers and microphones. Acoustic recordings from room microphones, wireless sensors, and stethoscope-like recordings will be analyzed to extract signal features and correlated with delivered bCPAP pressures and airway pressures transmitted to the lungs. The team will develop and test predictive models to estimate delivered and transmitted pressures from the acoustic signatures and report model performance and feasibility. This observational proof-of-concept work is designed to determine whether acoustic monitoring could serve as a non-invasive surrogate for routine pressure checks.
Why it matters
Potential benefit: If successful, this could provide a non-invasive, continuous way to monitor bCPAP effectiveness at the bedside and alert staff to leaks or obstructions sooner.
How similar studies have gone: This acoustic approach is relatively novel in neonatology; engineering and bench studies suggest bubbling acoustics relate to pressure but clinical proof in preterm infants remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants on bCPAP with gestational age \< 32+0 weeks * Postmenstrual age between 28+0 and 36+6 weeks at the time of the study * Postnatal age greater than 168 hours (7 days) at the time of the study * On the bubble CPAP device with binasal prongs at the time of the study * Receiving bubble CPAP levels of 5 to 7 cm H2O with gas flows between 6L/min and 10L/min at the time of the study Exclusion Criteria: * Infants with known major congenital anomalies * Infants with known congenital heart disorders * Infants with known neuromuscular disease * Infants receiving ventilator-derived CPAP at the time of the study * Infants receiving CPAP via a nasal mask interface at the time of the study * Infants receiving inotropes, narcotics or sedative agents at the time of the study * Infants deemed clinically unstable for the study by the attending neonatologist
Where it's running
-
McGill University Health Center
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Wissam Shalish, MD PhD — McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study coordinator: Wissam Shalish, MD, PhD
- Email: wissam.shalish@mcgill.ca
- Phone: 514-412-4400
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Detection of Respiratory Events in Extremely Preterm Infants Using Acoustic Monitoring
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.