Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants

NCT07552025 | Not Yet Recruiting

• 1 other identifier: 2026-11845
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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 rat, 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, we 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. Our 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. We 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, we hope to improve the management of these respiratory events and reduce the related health risks.

Conditions

Preterm Infant; Hypopnea; Apnea of Prematurity; Periodic Breathing

Keywords

Apnea of prematurity; Preterm infants; Diagnostic accuracy study; Respiratory acoustics; Respiratory events; Neonatal Intensive Unit Care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Extremely Preterm Infants

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

Healthcare Professionals-including physicians, nurses, and respiratory therapists-caring for study participants.

Other: Semi-structured interview

Interventions

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.

Extremely Preterm Infants

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.

Healthcare Professionals

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.

Extremely Preterm Infants

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.

Extremely Preterm Infants

Eligibility Criteria

• Age: Up to 29 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Extremely preterm infants hospitalized at the Neonatal Intensive Care Unit of the Montreal Children's Hospital.

You may qualify if:

• Infants with gestational age \< 29+0 weeks.
• Off respiratory support at the time of study recording.

You may not qualify if:

• Infants with known major congenital anomalies.
• Infants deemed clinically unstable for the study by the attending physician.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Apnea; Premature Birth

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Wissam Shalish

CONTACT

+1 514-412-4452; wissam.shalish@mcgill.ca

Research Coordinator

CONTACT

+1 514-934-1934; ana.saavedra.ruiz@muhc.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)