Infantile Apnea Clinical Trials

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Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants (DREAM 2)

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: f
View:

• Infants with gestational age \< 29+0 weeks.

• Off respiratory support at the time of study recording.

Locations
Other Locations
Canada
McGill University Health Centre
RECRUITING
Montreal
Contact Information
Primary
Wissam Shalish
wissam.shalish@mcgill.ca
+1 514-412-4452
Backup
Research Coordinator
ana.saavedra.ruiz@muhc.mcgill.ca
+1 514-934-1934
Time Frame
Start Date: 2026-05-28
Estimated Completion Date: 2028-09
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov