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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extremely Preterm Infants | Infants with gestational age < 29+0 weeks and off respiratory support at the time of study recording. |
| |
| Healthcare Professionals | Healthcare Professionals-including physicians, nurses, and respiratory therapists-caring for study participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wireless acoustic sensor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Extremely preterm infants hospitalized at the Neonatal Intensive Care Unit of the Montreal Children's Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wissam Shalish | Contact | +1 514-412-4452 | wissam.shalish@mcgill.ca | |
| Research Coordinator | Contact | +1 514-934-1934 | 78229 | ana.saavedra.ruiz@muhc.mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Wissam Shalish | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
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| Semi-structured interview | Other | 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. |
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| Nox T3s portable sleep monitoring device | Device | 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. |
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| Bedside monitor | Device | 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. |
|
| ID | Term |
|---|---|
| D001049 | Apnea |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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