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Clinical Trial NCT07060833 (Bubble CPAP) for Preterm Infant is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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McGill University Health Centre/Research Institute of the McGill University Health CentreAcoustics as a Metric of Airway Pressure in Premature Infants Using Bubble Continuous Positive Airway Pressure (Bubble CPAP) 30 Observational
Clinical Trial NCT07060833 (Bubble CPAP) is an observational study for Preterm Infant that is recruiting. It started on 3 April 2025 with plans to enroll 30 participants. Led by McGill University Health Centre/Research Institute of the McGill University Health Centre, it is expected to complete by 1 March 2026. The latest data from ClinicalTrials.gov was last updated on 11 July 2025.
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:
- To determine the relationship between ambient bubbling sounds and delivered pressures in preterm infants on bCPAP.
- To determine the relationship be...
Detailed Description
Continuous positive airway pressure (CPAP) is an essential, non-invasive therapy for treating various respiratory conditions in the Neonatal Intensive Care Units (NICU). CPAP is an effective treatment for respiratory distress syndrome, apneas, or after extubation, exerting its physiological benefits by maintaining upper airway patency and functional residual capacity. Bubble CPAP (bCPAP) is the most widely used CPAP ...Show More
Official Title
The Use of Bubble Continuous Positive Airway Pressure in Premature Infants: Acoustics as a Metric of Effective Pressure Delivery
Conditions
Preterm InfantOther Study IDs
- Bubble CPAP
- 2025-10708
NCT ID Number
Start Date (Actual)
2025-04-03
Last Update Posted
2025-07-11
Completion Date (Estimated)
2026-03
Enrollment (Estimated)
30
Study Type
Observational
Status
Recruiting
Keywords
Bubble CPAP
Airflow
Neonatal Intensive Care
Respiratory acoustics
Acoustic monitoring
Airway pressure monitoring
Bubbling sounds
Airflow
Neonatal Intensive Care
Respiratory acoustics
Acoustic monitoring
Airway pressure monitoring
Bubbling sounds
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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. | 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. |
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...Show More | 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 ta...Show More 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 Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
28 Weeks
Eligible Sexes
All
- 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
- 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
McGill University Health Centre/Research Institute of the McGill University Health Centre239 active studies to exploreNorthwestern UniversityStudy Responsible Party
Wissam Shalish, Principal Investigator, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Central Contact
Contact: Wissam Shalish, MD, PhD, 514-412-4400, [email protected]
1 Study Locations in 1 Countries
Quebec
McGill University Health Center, Montreal, Quebec, H4A 3J1, Canada
Wissam Shalish, MD, PhD, Contact, 514-412-4400, [email protected]
Wissam Shalish, MD PhD, Principal Investigator
Guilherme Sant'Anna, MD PhD, Sub-Investigator
Robert Kearney, MD PhD, Sub-Investigator
Recruiting