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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 7 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
McGill University Health Center
RECRUITING
Montreal
Contact Information
Primary
Wissam Shalish, MD, PhD
wissam.shalish@mcgill.ca
514-412-4400
Time Frame
Start Date: 2025-04-03
Estimated Completion Date: 2026-03
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Northwestern University
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov