Actively Recruiting

Age: 28Weeks - 32Weeks
All Genders
ID07060833

Acoustics as a Metric of Airway Pressure in Premature Infants Using Bubble Continuous Positive Airway Pressure

Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2026-03-30

30

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

M

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

N

Northwestern University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the use of bubble continuous positive airway pressure (bCPAP) in preterm infants born before 32 weeks gestation. This observational, proof-of-concept study aims to understand how the sounds produced by the bubbling in the bCPAP device relate to the airway pressures delivered to the infant's lungs. The goal is to develop models that predict these pressures from the acoustic properties of the bubbling sounds, potentially offering a new way to monitor therapy effectiveness in real time. The study involves two groups of 15 preterm infants each, all receiving bCPAP treatment in the neonatal intensive care unit. Group 1 will have their external bubble sounds and CPAP system pressures recorded using a microphone on the water tank and a pressure transducer in the expiratory limb for 3 hours. Group 2 will have similar measurements plus internal sounds and pressures recorded via a wireless sensor placed on the infant's suprasternal notch and an internal pressure transducer inserted into the nasopharynx, also for 3 hours. During the study, participants will be monitored for 3 hours with continuous recording of pressures and acoustic data. Researchers will assess external and internal bubble sounds alongside airway pressures. Data collection uses specialized devices to capture and store sound and pressure information for later analysis. The study helps evaluate the relationship between acoustic signals and pressure delivery in preterm infants on bCPAP, with the entire study expected to run until December 2026.

CONDITIONS

Brief Title

Acoustics as a Metric of Airway Pressure in Premature Infants Using Bubble Continuous Positive Airway Pressure

Who Can Participate

Age: 28Weeks - 32Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants on bubble CPAP with gestational age less than 32 weeks
  • Postmenstrual age between 28 and 36 weeks 6 days at study time
  • Postnatal age greater than 7 days at study time
  • Receiving bubble CPAP with binasal prongs during study
  • Receiving bubble CPAP levels of 5 to 7 cm H2O with gas flows between 6 and 10 L/min during study
Not Eligible

You will not qualify if you...

  • Infants with known major congenital anomalies
  • Infants with known congenital heart disorders
  • Infants with known neuromuscular disease
  • Infants receiving ventilator-derived CPAP during study
  • Infants receiving CPAP via nasal mask during study
  • Infants receiving inotropes, narcotics, or sedative agents during study
  • Infants deemed clinically unstable by attending neonatologist

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 3 hours

Participants on bubble continuous positive airway pressure (bCPAP) have their airway pressure and bubble sounds recorded using external and internal pressure transducers and acoustic sensors for analysis.

1 monitoring session lasting 3 hours

Trial Site Locations

Total: 1 location

1

McGill University Health Center

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

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Research Team

W

Wissam Shalish, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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