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RECRUITING
NCT07060833

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

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

View on ClinicalTrials.gov

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.

Official title: The Use of Bubble Continuous Positive Airway Pressure in Premature Infants: Acoustics as a Metric of Effective Pressure Delivery

Key Details

Gender

All

Age Range

28 Weeks - 32 Weeks

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-04-03

Completion Date

2026-12

Last Updated

2026-03-30

Healthy Volunteers

No

Conditions

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.

Locations (1)

McGill University Health Center

Montreal, Quebec, Canada