Preterm InfantBubble CPAPNCT07060833
Acoustics as a Metric of Airway Pressure in Premature Infants Using Bubble Continuous Positive Airway Pressure
An observational study of Preterm Infant, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 32 weeks
- Conditions the study is for
- Preterm Infant
- What is being tested?
- External pressure transducer, Standard microphone and Wireless acoustic sensor
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 3 Apr 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Center
Montreal, Quebec, H4A 3J1
Wissam Shalish, MD, PhD, 514-412-4400 ext. 22341, wissam.shalish@mcgill.ca
Wissam Shalish, MD PhD
About this study
Official title: The Use of Bubble Continuous Positive Airway Pressure in Premature Infants: Acoustics as a Metric of Effective Pressure Delivery
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 between transmitted bubbling sounds and airway pressures transmitted to the lungs of preterm infants on bCPAP.
- To develop models to predict delivered and transmitted bCPAP pressures from the acoustic properties of bubbling sounds.
Read the 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 due to its low cost and ease of use. It consists of an inspiratory tube carrying heated and humidified air, a nasal interface, and an expiratory tube immersed in a water chamber. The generation of bubbles in the water chamber by exhaled gas creates low amplitude and high-frequency pressure oscillations that are transmitted back to the chest. Successful CPAP requires constant transmission of the pressure via an unobstructed circuit. However, this is difficult to achieve in practice due to inadequate interface, leaks from an open mouth, and obstructed airway. As a result, bCPAP requires frequent manual checks by nurses and respiratory therapists to ensure that the circuit is secure and unobstructed.
As a proposed solution, bCPAP sounds heard in the patient room or upon auscultation are routinely used to assess the effectiveness of CPAP therapy. This sound can be heard both from the water tank creating the vibrations and during auscultation with a stethoscope, as the sound vibration is transmitted to the neonatal lungs. In the current era of digital technology, acoustic sounds can be converted to electronic signals for further processing and analysis.
We hypothesize that continuous recording and analysis of bCPAP sounds could be used as a proxy for real-time objective monitoring of the pressure transmitted to infants' lungs.
- Conditions
- Preterm Infant
- Being tested
- External pressure transducer, Standard microphone, Wireless acoustic sensor, Internal pressure transducer
- Keywords
- Bubble CPAP, Airflow, Neonatal Intensive Care, Respiratory acoustics, Acoustic monitoring, Airway pressure monitoring, Bubbling sounds
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External pressure transducerDevice
Also called External catheter pressure transducer (Millar Mikro-tip ® SPR-524, 3.5F Single straight, Texas)
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 microphoneDevice
Also called Lavalier condenser microphone, Tosuny
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 sensorDevice
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 transducerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: External pressure transducer; Device: Standard microphone; Device: Wireless acoustic sensor; Device: Internal pressure transducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure
The mean pressure and the standard deviation of the pressure will be computed for each segment.
Measured: 3 hours
External bubble CPAP sounds
Two metrics will be computed:
- The root mean square (RMS)
- 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.
Measured: 3 hours
Internal bubble CPAP sounds
- We will apply biomedical signal processing methods to separate the bubbling sounds from breathing sounds. Then, RMS and power will be computed.
- 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.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start3 Apr 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Principal investigator, Wissam Shalish, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Wissam Shalish, MD PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060833
- Sponsor's protocol ID
- 2025-10708
- Other IDs
- 2025
- Acronym
- Bubble CPAP
- Status last verified
- Mar 2026
- First submitted
- 2 Jul 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Bubble Continuous Positive Airway Pressure in Premature Infants: Acoustics as a Metric of Effective Pressure Delivery
- ClinicalTrials.gov ID
- NCT07060833
- Acronym / sponsor ID
- Bubble CPAP / 2025-10708
- Conditions
- Preterm Infant
- Keywords
- Bubble CPAP, Airflow, Neonatal Intensive Care, Respiratory acoustics, Acoustic monitoring, Airway pressure monitoring, Bubbling sounds
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 between transmitted bubbling sounds and airway pressures transmitted to the lungs of preterm infants on bCPAP.
- To develop models to predict delivered and transmitted bCPAP pressures from the acoustic properties of bubbling sounds.
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 due to its low cost and ease of use. It consists of an inspiratory tube carrying heated and humidified air, a nasal interface, and an expiratory tube immersed in a water chamber. The generation of bubbles in the water chamber by exhaled gas creates low amplitude and high-frequency pressure oscillations that are transmitted back to the chest. Successful CPAP requires constant transmission of the pressure via an unobstructed circuit. However, this is difficult to achieve in practice due to inadequate interface, leaks from an open mouth, and obstructed airway. As a result, bCPAP requires frequent manual checks by nurses and respiratory therapists to ensure that the circuit is secure and unobstructed.
As a proposed solution, bCPAP sounds heard in the patient room or upon auscultation are routinely used to assess the effectiveness of CPAP therapy. This sound can be heard both from the water tank creating the vibrations and during auscultation with a stethoscope, as the sound vibration is transmitted to the neonatal lungs. In the current era of digital technology, acoustic sounds can be converted to electronic signals for further processing and analysis.
We hypothesize that continuous recording and analysis of bCPAP sounds could be used as a proxy for real-time objective monitoring of the pressure transmitted to infants' lungs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I: 15 preterm infants on Bubble Continuous Positive Airway Pressure (bCPAP) | – | Device: External pressure transducer, Device: Standard microphoneGroup 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) | – | Device: External pressure transducer, Device: Standard microphone, Device: Wireless acoustic sensor, Device: Internal pressure transducerGroup 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. |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External pressure transducerAlso: External catheter pressure transducer (Millar Mikro-tip ® SPR-524, 3.5F Single straight, Texas)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 | 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 microphoneAlso: Lavalier condenser microphone, TosunyThe 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 | 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 sensorThe 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 | Phase II: 15 preterm infants on Bubble Continuous Positive Airway Pressure (bCPAP) |
| Internal pressure transducerThe 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. | Device | Phase II: 15 preterm infants on Bubble Continuous Positive Airway Pressure (bCPAP) |
Primary outcome
Pressure
Time frame: 3 hours
The mean pressure and the standard deviation of the pressure will be computed for each segment.
External bubble CPAP sounds
Time frame: 3 hours
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.
Internal bubble CPAP sounds
Time frame: 3 hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wissam Shalish, MD PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infant, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wissam Shalish, MD, PhD (514-412-4400 ext. 22341, wissam.shalish@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure (time frame: 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.