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

NCT07060833 | Recruiting

• 1 other identifier: 2025-10708
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Preterm Infant

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Pressure

  The mean pressure and the standard deviation of the pressure will be computed for each segment.

  3 hours

• External bubble CPAP sounds

  Two metrics will be computed: 1. The root mean square (RMS) 2. The power contained between a pre-determined range within each segment; We will determine the range that contains 80% of the signal power, in order to minimize other noises from bubble CPAP signal.

  3 hours

• Internal bubble CPAP sounds

  1. We will apply biomedical signal processing methods to separate the bubbling sounds from breathing sounds. Then, RMS and power will be computed. 2. We will use the Pearson correlation coefficient to compute the relationship between bubbling sound and pressure metrics. We will evaluate the linear regression models to identify the combination of sound metrics and covariates with the highest predictive accuracy.

  3 hours

Study Arms (2)

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.

Device: External pressure transducer; Device: Standard microphone

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.

Device: External pressure transducer; Device: Standard microphone; Device: Wireless acoustic sensor; Device: Internal pressure transducer

Interventions

External pressure transducer DEVICE

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.

Also known as: External catheter pressure transducer (Millar Mikro-tip ® SPR-524, 3.5F Single straight, Texas)

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

Standard microphone DEVICE

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.

Also known as: Lavalier condenser microphone, Tosuny

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

Wireless acoustic sensor DEVICE

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.

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

Internal pressure transducer DEVICE

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.

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

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Wissam Shalish, MD PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wissam Shalish, MD, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)