Using bubble CPAP sounds to measure airway pressure in premature infants
The Use of Bubble Continuous Positive Airway Pressure in Premature Infants: Acoustics as a Metric of Effective Pressure Delivery
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 28 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT07060833 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Montreal, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.