Apnea of PrematurityDREAMNCT05196646
Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP
An observational study of Apnea of Prematurity, 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 50 preterm infants with gestational age < 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital. Read more about this study
- Who is it for?
- Ages 72 hours and older
- Conditions the study is for
- Apnea of Prematurity
- What is being tested?
- Respiratory Acoustic Sensors, Nasal thermistor and Respiratory Inductive Plethysmography
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 5 Dec 2022to 31 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 72 hours and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital.
Who may be able to join
- Gestational age < 32+0 weeks
- Postmenstrual age between 28+0 and 36+6 weeks.
- Additional inclusion criteria for Groups 1 and 2:
- Off any respiratory support and breathing in-room air
- Less than 3 clinically significant cardiorespiratory events per calendar day
- Additional inclusion criteria for Group 3:
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- On the bubble CPAP device with the binasal prongs interface
- Receiving CPAP levels of 5 to 7 cm H2O with gas flows not exceeding 10L/min
- At least 3 clinically significant cardiorespiratory events per calendar day
Who cannot join
- Major known congenital abnormalities
- Known congenital heart disorders
- Known neuromuscular disease
- Known diaphragmatic paralysis or a diagnosed phrenic nerve injury
- History of esophageal perforation in the 7 days preceding the study
- History of pneumothorax requiring chest tube insertion in the 7 days preceding the study
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- Receiving inotropes, narcotics, or sedative agents at the time of study recording
- Additional exclusions at the time of the study recording:
- Infants receiving ventilator-derived CPAP
- Infants receiving CPAP via a nasal mask interface.
- Infants receiving inotropes, narcotics or sedative agents
- Infants deemed clinically unstable for the study by the attending neonatologist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on Continuous Positive Airway Pressure: the DREAM Pilot Project
This is an observational, proof-of-concept, feasibility study where 50 preterm infants 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 primary objective is to describe the relationship between respiratory acoustics and airflow and determine the reliability of a novel respiratory acoustic sensor at detecting breathing sounds in preterm infants.
Read more
The study's secondary objectives are:
- To compare transthoracic impedance, respiratory inductive plethysmography and an inertial measurement unit for the detection of respiratory efforts in preterm infants.
- To evaluate the feasibility and accuracy of a novel, non-invasive method for continuously detecting and differentiating cardiorespiratory events in preterm infants on CPAP by integrating measurements of respiratory effort with respiratory acoustic monitoring.
Read the detailed description
Cardiorespiratory events, defined by the occurrence of apneas, bradycardias, and desaturations, are almost ubiquitous in very preterm infants and are associated with numerous complications. Unfortunately, the current standard for monitoring cardiorespiratory events in the NICU, transthoracic impedance (TTI), does not permit for accurate differentiation of the different types of cardiorespiratory events; TTI cannot detect airflow and has low accuracy for detecting respiratory efforts. As a result, TTI does not detect obstructive apneas and may not reliably capture all central apneas.
Respiratory sounds are an attractive surrogate measure of airflow, and can be captured using respiratory acoustic technology (akin to a miniaturized electronic stethoscope). We hypothesize that respiratory acoustic monitoring can provide a continuous, non-invasive, and accurate representation of airflow and breathing sounds in preterm infants.
Altogether, we conjecture that the combination of respiratory acoustic monitoring with measurements of respiratory effort will improve the ability to differentiate and describe the nature of cardiorespiratory events in preterm infants.
- Conditions
- Apnea of Prematurity
- Being tested
- Respiratory Acoustic Sensors, Nasal thermistor, Respiratory Inductive Plethysmography, Pneumotachometer
- Keywords
- Airflow, Apnea, Cardiorespiratory events, Monitoring, Neonatal Intensive Care, Preterm infants, Respiratory acoustics, Prematurity, CPAP, Acoustic monitoring
- Medical subject headings
- Apnea, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Acoustic SensorsDevice
Wireless sensor that contains a dual microphone and an inertial measurement unit (IMU) will capture the breathing sound and respiratory effect. Two wireless sensors will be used, with one placed on the suprasternal notch and the other placed on the right upper chest of the infant, in order to determine the sensor placement yielding the best respiratory signal. Data will be transmitted in real-time to a research-dedicated tablet using the Bluetooth Communication Controller (ISP1807, Insight SIP) and stored on the same device for future analysis.
Nasal thermistorDevice
Also called MLT415/A®, ADInstruments®, Bella Vista, Australia
The nasal temperature probe that detects changes in temperature between inhaled and exhaled gases allows for the surrogate measure of airflow. It will be placed in one naris and secured with tape at the upper lip or cheek. The nasal temperature signal will be acquired using the Power Lab analog-digital acquisition system and stored for later analysis.
Respiratory Inductive PlethysmographyDevice
Also called SleepSense®, Scientific Laboratory Products, Elgin, USA
Two respiratory bands will be placed circumferentially around the infant's chest (at the level of nipple line) and around the abdomen (just above the level of the umbilicus) in order to measure chest and abdominal wall movements, respectively. These movements will be recorded using Respiratory Inductive Plethysmography (Respitrace QDC®, Viasys® Healthcare, USA). The Respitrace® signals will be acquired using the Power Lab data acquisition system and stored for later analysis.
PneumotachometerDevice
Also called Hans Rudolph, Inc, Shawnee, KS
The pneumotachometer is a pressure-differential based flow sensor that is used to measure respiratory flow. It will be connected to a standard face mask that is gently applied to cover the infant's mouth and nose. The face mask will be similar to the masks used as part of standard of care in the NICU for infants who require continuous positive pressure, with or without ventilation. The flow measurements will be recorded using the Power Lab data acquisition system and stored for later analysis.
| Study group | Role | What they receive |
|---|---|---|
| (1) 10 preterm infants spontaneously breathing in-room air with no respiratory support | Group 1 will consist of 10 preterm infants spontaneously breathing in room air, with no respiratory support, in whom respiratory acoustic signals from the acoustic sensor will be compared with airflow measurements obtained using a pneumotachometer, i.e. the gold standard. Data will be acquired for 10 minutes. Receives: Device: Respiratory Acoustic Sensors; Device: Pneumotachometer | |
| (2) 20 preterm infants spontaneously breathing in-room air with no respiratory support | Group 2 will consist of 20 preterm infants spontaneously breathing in room air, with no respiratory support, in whom respiratory acoustic signals from the acoustic sensor will be compared with airflow measurements obtained using a nasal temperature sensor. In addition, measurements of respiratory efforts will be obtained using the Respiratory Inductance Plethysmography (RIP), an inertial measurement unit (IMU) integrated within the acoustic sensor, and the Transthoracic Impedance (TTI) from the bedside monitor. Data will be continuously recorded for 3 hours. Receives: Device: Respiratory Acoustic Sensors; Device: Nasal thermistor; Device: Respiratory Inductive Plethysmography | |
| (3) 20 preterm infants on continuous positive airway pressure (CPAP) with cardiorespiratory events | Group 3 will consist of 10 preterm infants on CPAP with established cardiorespiratory events, in whom respiratory acoustic signals from the acoustic sensor will be continuously measured for 3 hours. In addition, measurements of respiratory efforts will be obtained using the Respiratory Inductance Plethysmography (RIP), an inertial measurement unit (IMU) integrated within the acoustic sensor, and the Transthoracic Impedance (TTI). Data will be continuously recorded for 3 hours. Receives: Device: Respiratory Acoustic Sensors; Device: Respiratory Inductive Plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of respiratory acoustics at detecting airflow compared to airflow measurements obtained from a pneumotachometer.
The airflow signal derived from the respiratory acoustic sensor will be compared with the airflow signal derived from the pneumotachometer.
Measured: 10 minutes (group 1) or 3 hours (groups 2 and 3)
Secondary outcomes (2)
Reliability of the inertial measurement unit (IMU) at detecting respiratory efforts compared to Respiratory Inductance Plethysmography (RIP).
The chest wall movement signal derived from the respiratory acoustic sensor will be compared with the chest wall movement signal derived from RIP.
Measured: 3 hours (groups 2 and 3 only)
Reliability of the inertial measurement unit (IMU) at detecting respiratory efforts compared to Transthoracic Impedance (TTI).
The chest wall movement signal derived from the respiratory acoustic sensor will be compared with the chest wall movement signal derived from TTI.
Measured: 3 hours (groups 2 and 3 only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start5 Dec 2022
- Primary completion28 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea of PrematurityStudies 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
- 50 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 M Shalish, MD PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196646
- Sponsor's protocol ID
- 2022-7444
- Acronym
- DREAM
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2021
- 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
- Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on Continuous Positive Airway Pressure: the DREAM Pilot Project
- ClinicalTrials.gov ID
- NCT05196646
- Acronym / sponsor ID
- DREAM / 2022-7444
- Conditions
- Apnea of Prematurity
- Keywords
- Airflow, Apnea, Cardiorespiratory events, Monitoring, Neonatal Intensive Care, Preterm infants, Respiratory acoustics, Prematurity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Jan 2022 (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 50 preterm infants 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 primary objective is to describe the relationship between respiratory acoustics and airflow and determine the reliability of a novel respiratory acoustic sensor at detecting breathing sounds in preterm infants.
The study's secondary objectives are:
- To compare transthoracic impedance, respiratory inductive plethysmography and an inertial measurement unit for the detection of respiratory efforts in preterm infants.
- To evaluate the feasibility and accuracy of a novel, non-invasive method for continuously detecting and differentiating cardiorespiratory events in preterm infants on CPAP by integrating measurements of respiratory effort with respiratory acoustic monitoring.
Detailed description
Cardiorespiratory events, defined by the occurrence of apneas, bradycardias, and desaturations, are almost ubiquitous in very preterm infants and are associated with numerous complications. Unfortunately, the current standard for monitoring cardiorespiratory events in the NICU, transthoracic impedance (TTI), does not permit for accurate differentiation of the different types of cardiorespiratory events; TTI cannot detect airflow and has low accuracy for detecting respiratory efforts. As a result, TTI does not detect obstructive apneas and may not reliably capture all central apneas.
Respiratory sounds are an attractive surrogate measure of airflow, and can be captured using respiratory acoustic technology (akin to a miniaturized electronic stethoscope). We hypothesize that respiratory acoustic monitoring can provide a continuous, non-invasive, and accurate representation of airflow and breathing sounds in preterm infants.
Altogether, we conjecture that the combination of respiratory acoustic monitoring with measurements of respiratory effort will improve the ability to differentiate and describe the nature of cardiorespiratory events in preterm infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| (1) 10 preterm infants spontaneously breathing in-room air with no respiratory support | – | Device: Respiratory Acoustic Sensors, Device: PneumotachometerGroup 1 will consist of 10 preterm infants spontaneously breathing in room air, with no respiratory support, in whom respiratory acoustic signals from the acoustic sensor will be compared with airflow measurements obtained using a pneumotachometer, i.e. the gold standard. Data will be acquired for 10 minutes. |
| (2) 20 preterm infants spontaneously breathing in-room air with no respiratory support | – | Device: Respiratory Acoustic Sensors, Device: Nasal thermistor, Device: Respiratory Inductive PlethysmographyGroup 2 will consist of 20 preterm infants spontaneously breathing in room air, with no respiratory support, in whom respiratory acoustic signals from the acoustic sensor will be compared with airflow measurements obtained using a nasal temperature sensor. In addition, measurements of respiratory efforts will be obtained using the Respiratory Inductance Plethysmography (RIP), an inertial measurement unit (IMU) integrated within the acoustic sensor, and the Transthoracic Impedance (TTI) from the bedside monitor. Data will be continuously recorded for 3 hours. |
| (3) 20 preterm infants on continuous positive airway pressure (CPAP) with cardiorespiratory events | – | Device: Respiratory Acoustic Sensors, Device: Respiratory Inductive PlethysmographyGroup 3 will consist of 10 preterm infants on CPAP with established cardiorespiratory events, in whom respiratory acoustic signals from the acoustic sensor will be continuously measured for 3 hours. In addition, measurements of respiratory efforts will be obtained using the Respiratory Inductance Plethysmography (RIP), an inertial measurement unit (IMU) integrated within the acoustic sensor, and the Transthoracic Impedance (TTI). Data will be continuously recorded for 3 hours. |
Who may qualify
- Ages
- 72 hours and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital.
Key inclusion criteria (9 listed)
- Gestational age < 32+0 weeks
- Postmenstrual age between 28+0 and 36+6 weeks.
- Off any respiratory support and breathing in-room air
- Less than 3 clinically significant cardiorespiratory events per calendar day
- On the bubble CPAP device with the binasal prongs interface
Key exclusion criteria (12 listed)
- Major known congenital abnormalities
- Known congenital heart disorders
- Known neuromuscular disease
- Known diaphragmatic paralysis or a diagnosed phrenic nerve injury
- History of esophageal perforation in the 7 days preceding 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 |
|---|---|---|
| Respiratory Acoustic SensorsWireless sensor that contains a dual microphone and an inertial measurement unit (IMU) will capture the breathing sound and respiratory effect. Two wireless sensors will be used, with one placed on the suprasternal notch and the other placed on the right upper chest of the infant, in order to determine the sensor placement yielding the best respiratory signal. Data will be transmitted in real-time to a research-dedicated tablet using the Bluetooth Communication Controller (ISP1807, Insight SIP) and stored on the same device for future analysis. | Device | (1) 10 preterm infants spontaneously breathing in-room air with no respiratory support, (2) 20 preterm infants spontaneously breathing in-room air with no respiratory support, (3) 20 preterm infants on continuous positive airway pressure (CPAP) with cardiorespiratory events |
| Nasal thermistorAlso: MLT415/A®, ADInstruments®, Bella Vista, AustraliaThe nasal temperature probe that detects changes in temperature between inhaled and exhaled gases allows for the surrogate measure of airflow. It will be placed in one naris and secured with tape at the upper lip or cheek. The nasal temperature signal will be acquired using the Power Lab analog-digital acquisition system and stored for later analysis. | Device | (2) 20 preterm infants spontaneously breathing in-room air with no respiratory support |
| Respiratory Inductive PlethysmographyAlso: SleepSense®, Scientific Laboratory Products, Elgin, USATwo respiratory bands will be placed circumferentially around the infant's chest (at the level of nipple line) and around the abdomen (just above the level of the umbilicus) in order to measure chest and abdominal wall movements, respectively. These movements will be recorded using Respiratory Inductive Plethysmography (Respitrace QDC®, Viasys® Healthcare, USA). The Respitrace® signals will be acquired using the Power Lab data acquisition system and stored for later analysis. | Device | (2) 20 preterm infants spontaneously breathing in-room air with no respiratory support, (3) 20 preterm infants on continuous positive airway pressure (CPAP) with cardiorespiratory events |
| PneumotachometerAlso: Hans Rudolph, Inc, Shawnee, KSThe pneumotachometer is a pressure-differential based flow sensor that is used to measure respiratory flow. It will be connected to a standard face mask that is gently applied to cover the infant's mouth and nose. The face mask will be similar to the masks used as part of standard of care in the NICU for infants who require continuous positive pressure, with or without ventilation. The flow measurements will be recorded using the Power Lab data acquisition system and stored for later analysis. | Device | (1) 10 preterm infants spontaneously breathing in-room air with no respiratory support |
Primary outcome
Reliability of respiratory acoustics at detecting airflow compared to airflow measurements obtained from a pneumotachometer.
Time frame: 10 minutes (group 1) or 3 hours (groups 2 and 3)
The airflow signal derived from the respiratory acoustic sensor will be compared with the airflow signal derived from the pneumotachometer.
2 secondary outcomes
Reliability of the inertial measurement unit (IMU) at detecting respiratory efforts compared to Respiratory Inductance Plethysmography (RIP).
Time frame: 3 hours (groups 2 and 3 only)
Reliability of the inertial measurement unit (IMU) at detecting respiratory efforts compared to Transthoracic Impedance (TTI).
Time frame: 3 hours (groups 2 and 3 only)
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. This study is not recruiting at the moment.
Wissam M 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 Apnea of Prematurity, 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 9 inclusion and 12 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: under way, not looking for participants, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of respiratory acoustics at detecting airflow compared to airflow measurements obtained from a pneumotachometer. (time frame: 10 minutes (group 1) or 3 hours (groups 2 and 3)). 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.