Clinical Trial

Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants

Study acronym: DREAM 2
Not Yet Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-20.
Trial Details
NCT Number NCT07552025
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions Apnea of Prematurity, Preterm Infant, Periodic Breathing, Hypopnea
Enrollment 50 participants
Start Date 2026-05
Primary Completion 2027-12 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-12