Recruiting

Observational Study

Sponsor:

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

Code:

NCT07060833

Conditions

Preterm Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

External pressure transducer

Standard microphone

Wireless acoustic sensor

Internal pressure transducer

Study Details

Brief 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

Study ID

NCT07060833

Start date

Apr 3, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Phase I: 15 preterm infants on Bubble Continuous Positive Airway Pressure (bCPAP)

Group 1 will consist of 15 preterm infants on bCPAP in whom the external bubble CPAP sounds and the pressures from the CPAP system itself will be recorded for 3 hours. To do so, we will use a standard microphone placed on the water tank and an external pressure transducer inserted into the expiratory limb of the bubble CPAP circuit.

Phase II: 15 preterm infants on Bubble Continuous Positive Airway Pressure (bCPAP)

Group 2 will consist of 15 preterm infants on bCPAP in whom the external bubble CPAP sounds and the pressures from the CPAP system itself will be recorded. To do so, we will use a standard microphone placed on the water tank and a pressure transducer inserted into the expiratory limb of the bubble CPAP circuit. In addition, the internal bubble CPAP sound and pressure transmitted to the infant's lungs will be measured. For these, a wireless acoustic sensor will be secured on the infant's suprasternal notch to capture transmitted CPAP sounds, and an internal pressure transducer will be inserted from the infant's mouth into the nasopharynx to record the pressure delivered in the airway. Data will be recorded for 3 hours.

Interventions

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.

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.

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.

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.

Primary outcome measure

  • Pressure [ Time Frame: 3 hours ]
  • External bubble CPAP sounds [ Time Frame: 3 hours ]
  • Internal bubble CPAP sounds [ Time Frame: 3 hours ]

Central Contacts and Locations

Central contacts

Wissam Shalish, MD, PhD

514-412-4400wissam.shalish@mcgill.ca

Locations

McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Wissam Shalish, MD, PhD

514-412-4400wissam.shalish@mcgill.ca

Principal Investigator:

Wissam Shalish, MD PhD

More Information

Sponsor

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

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • Bubble CPAP
  • Airflow
  • Neonatal Intensive Care
  • Respiratory acoustics
  • Acoustic monitoring
  • Airway pressure monitoring
  • Bubbling sounds

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-03-30.