An observational study in Apnea of Prematurity, Preterm Infant and Periodic Breathing, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to participants aged Up to 29 Weeks. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational
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.
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.
282 studies on the registry are indexed under Apnea; 54 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 78 observational studies indexed under Apnea.
Browse Apnea studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
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Extremely preterm infants hospitalized at the Neonatal Intensive Care Unit of the Montreal Children's Hospital.
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Exclusion Criteria:
Infants with gestational age \< 29+0 weeks and off respiratory support at the time of study recording.
Device: Wireless acoustic sensor · Device: Nox T3s portable sleep monitoring device · Device: Bedside monitor
Healthcare Professionals-including physicians, nurses, and respiratory therapists-caring for study participants.
Other: Semi-structured interview
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.
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.
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.
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.
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.
Time frame: 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
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2027, 19 months after the start.
Of 35 observational studies under Apnea, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 38. This study's planned 19 months is below that.
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