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

NCT07060833 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-03-30

No results posted yet for this study

Summary

This is an observational, proof-of-concept, feasibility study where 30 preterm infants on bubble CPAP with gestational age \< 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital.

The study's main goals are:

1. To determine the relationship between ambient bubbling sounds and delivered pressures in preterm infants on bCPAP.
2. To determine the relationship between transmitted bubbling sounds and airway pressures transmitted to the lungs of preterm infants on bCPAP.
3. To develop models to predict delivered and transmitted bCPAP pressures from the acoustic properties of bubbling sounds.

Conditions

  • Preterm Infant

Interventions

DEVICE

External pressure transducer

The delivered CPAP pressure will be measured using an ultra-thin, multi-use catheter pressure transducer inserted into a port in the expiratory limb of the bubble CPAP circuit.

DEVICE

Standard microphone

The bubble sound of the water tank will be collected with a standard condenser microphone directly affixed to the pole holding the water tank, with a secure clip.

DEVICE

Wireless acoustic sensor

The wireless acoustic sensor contains a dual microphone capable of capturing target sounds as well as ambient noise. The frequencies associated with ambient noise will be subtracted to maximize the signal-to-noise ratio of the bubble sound waveform. The wireless sensor will be placed on the suprasternal notch of the infant for monitoring the bubble sounds transmitted to the lungs and secured using a silicone-based tape approved for use in neonates. Data will be transmitted in real-time to a research-dedicated tablet using the Bluetooth Communication Controller and stored for future analysis.

DEVICE

Internal pressure transducer

The transmitted CPAP pressure will be measured using an ultra-thin, single-use catheter pressure transducer inserted through the mouth to the level of the infant's nasopharynx. The data will be acquired with a sampling rate of 10kHz and stored for later analysis.

Sponsors & Collaborators

  • Northwestern University

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Wissam Shalish, MD PhD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility

Min Age
28 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07060833 on ClinicalTrials.gov