Apnea of PrematurityDREAM 2NCT07552025
Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants
An observational study of Apnea of Prematurity and Preterm Infant, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems. These respiratory events include pauses in breathing, shallows breaths, and irregular breathing patterns. Read more about this study
- Who is it for?
- Ages Up to 29 weeks
- Conditions the study is for
- Apnea of Prematurity, Preterm Infant, Periodic Breathing
- What is being tested?
- Wireless acoustic sensor, Semi-structured interview and Nox T3s portable sleep monitoring device
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 28 May 2026to Sep 2028
- How long will I take part?
- 9 Weeks
- Phase
- Observational
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 Up to 29 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Extremely preterm infants hospitalized at the Neonatal Intensive Care Unit of the Montreal Children's Hospital.
Who may be able to join
- Infants with gestational age < 29+0 weeks.
- Off respiratory support at the time of study recording.
Who cannot join
- Infants with known major congenital anomalies.
- Infants deemed clinically unstable for the study by the attending physician.
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 Centre
Montreal, Quebec, H4A 3J1
Wissam Shalish, 514-412-4452, wissam.shalish@mcgill.ca
Wissam Shalish
About this study
Official title: Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants (DREAM 2)
Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems. These respiratory events include pauses in breathing, shallows breaths, and irregular breathing patterns. These problems are most common right after birth but can continue for weeks, leading to extended hospital stays, higher medical costs, and potential long-term health concerns affecting the eyes, lungs, and brain.
Currently, neonatal intensive care units (NICUs) use methods like measuring oxygen levels, heart rate, and electrical resistance in the chest to monitor for respiratory events. However, these methods have limitations. For instance, they cannot accurately measure airflow and do not distinguish between different types of respiratory events. As a results, some breathing problems might go unnoticed or be managed improperly.
Read more
To address this, the investigators have developed a wireless acoustic sensor that uses advanced microphones and motion sensors to record airflow and chest movements. In initial tests with healthy preterm infants, this sensor proved reliable in detecting breathing patterns and airway obstruction, suggesting it could offer a more precise and non-invasive monitoring method.
This study aims to assess how well this new sensor performs compared to existing methods in detecting and distinguishing different types of respiratory events in a high-risk group of extremely preterm infants. The investigators will track respiratory patterns in extremely preterm infants at various stages between 32 and 44 weeks of age. By comparing the new sensor's performance with currents standards and gold-standard methods, the investigators hope to improve the management of these respiratory events and reduce the related health risks.
- Conditions
- Apnea of Prematurity, Preterm Infant, Periodic Breathing, Hypopnea
- Being tested
- Wireless acoustic sensor, Semi-structured interview, Nox T3s portable sleep monitoring device, Bedside monitor
- Keywords
- Apnea of prematurity, Preterm infants, Diagnostic accuracy study, Respiratory acoustics, Respiratory events, Neonatal Intensive Unit Care
- 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.
Wireless acoustic sensorDevice
Airflow and respiratory effort will be measured using a single wireless acoustic sensor placed at the infant's suprasternal notch. Measurements will be performed at four postmenstrual age (PMA) intervals: 32 + 0 to 33 + 6 weeks, 34 + 0 to 36 + 6 weeks, 37 + 0 to 39 + 6 weeks, and 40 + 0 to 43 + 6 weeks. At each time point, data will be collected during a continuous 3-hour recording period with the infant positioned supine.
Semi-structured interviewOther
A 20-minute semi-structured interview will be conducted by one trained team member with healthcare professionals to explore and assess their perspectives on the current limitations and clinical acceptance of using a wireless acoustic sensor for monitoring respiratory events in the NICU.
Nox T3s portable sleep monitoring deviceDevice
Breathing efforts will be measured using two RIP bands placed around the chest and abdomen of the infant, respectively. Airflow will be measured using a nasal pressure transducer via prongs placed on the infant's nostrils. Both measurements will be obtained using a Nox T3s portable sleep monitoring device (Nox Medical, Reykjavik, Iceland). Measurements will be performed at four postmenstrual age (PMA) intervals: 32 + 0 to 33 + 6 weeks, 34 + 0 to 36 + 6 weeks, 37 + 0 to 39 + 6 weeks, and 40 + 0 to 43 + 6 weeks. At each time point, data will be collected during a continuous 3-hour recording period with the infant positioned supine.
Bedside monitorDevice
Cardiorespiratory waveform data (TTI, SpO2, and HR) will be directly extracted from the infant's bedside monitor.
All acquired signals will be aggregated and synchronized a posteriori onto a user-friendly interface.
| Study group | Role | What they receive |
|---|---|---|
| Extremely Preterm Infants | Infants with gestational age < 29+0 weeks and off respiratory support at the time of study recording. Receives: Device: Wireless acoustic sensor; Device: Nox T3s portable sleep monitoring device; Device: Bedside monitor | |
| Healthcare Professionals | Healthcare Professionals-including physicians, nurses, and respiratory therapists-caring for study participants. Receives: Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory events
A respiratory event will be defined as any drop in airflow signal ≥ 90% for > 3sec, or any partial drop in airflow signal ≥ 30% of pre-event baseline for > 3sec if followed by desaturation (SpO2 < 90%) and/or bradycardia (heart rate < 80bpm). Events will be differentiated into five groups based on extra criteria: (1) isolated central apneas: no rib cage or abdominal excursions; (2) periodic breathing: ≥ 3 breaths interrupted by central apneas; (3) obstructive apnea: ≥ 90% drop in airflow signal but intact rib cage and abdominal excursions; (4) hypopnea: partial drop in airflow signal, with or without rib cage and abdominal excursions; (5) mixed apnea: central followed by obstructive apnea, or vice versa.
Measured: At four time points, over a 3-hour period, between: (1) 32+0-33+6 weeks PMA; (2) 34+0-36+6 weeks PMA; (3) 37+0-39+6 weeks PMA; (4) 40+0-43+6 weeks PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start28 May 2026
- Primary completionDec 2027 (estimated)
- Study completionSep 2028 (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.
- 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)
- Target duration
- 9 Weeks
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Wissam Shalish, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Wissam Shalish, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552025
- Sponsor's protocol ID
- 2026-11845
- Acronym
- DREAM 2
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No