Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants

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 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.

Conditions

• Apnea of Prematurity
• Preterm Infant
• Periodic Breathing
• Hypopnea

Interventions

DEVICE

Wireless acoustic sensor

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.

OTHER

Semi-structured interview

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.

DEVICE

Nox T3s portable sleep monitoring 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.

DEVICE

Bedside monitor

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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Wissam Shalish · McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility

Max Age

29 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2027-12-31

Completion

2028-09-30

Countries

• Canada

Study Locations