Status:
ACTIVE_NOT_RECRUITING
Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Northwestern University
Conditions:
Apnea of Prematurity
Eligibility:
All Genders
72+ years
Brief Summary
This is an observational, proof-of-concept, feasibility study where 50 preterm infants with gestational age \< 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal...
Detailed Description
Cardiorespiratory events, defined by the occurrence of apneas, bradycardias, and desaturations, are almost ubiquitous in very preterm infants and are associated with numerous complications. Unfortunat...
Eligibility Criteria
Inclusion
- Inclusion Criteria for all infants:
- Gestational age \< 32+0 weeks
- Postmenstrual age between 28+0 and 36+6 weeks.
- Additional inclusion criteria for Groups 1 and 2:
- Off any respiratory support and breathing in-room air
- Less than 3 clinically significant cardiorespiratory events per calendar day
- Additional inclusion criteria for Group 3:
- On the bubble CPAP device with the binasal prongs interface
- Receiving CPAP levels of 5 to 7 cm H2O with gas flows not exceeding 10L/min
- At least 3 clinically significant cardiorespiratory events per calendar day
- Exclusion Criteria:
- Major known congenital abnormalities
- Known congenital heart disorders
- Known neuromuscular disease
- Known diaphragmatic paralysis or a diagnosed phrenic nerve injury
- History of esophageal perforation in the 7 days preceding the study
- History of pneumothorax requiring chest tube insertion in the 7 days preceding the study
- Receiving inotropes, narcotics, or sedative agents at the time of study recording
- Additional exclusions at the time of the study recording:
- Infants receiving ventilator-derived CPAP
- Infants receiving CPAP via a nasal mask interface.
- Infants receiving inotropes, narcotics or sedative agents
- Infants deemed clinically unstable for the study by the attending neonatologist.
Exclusion
Key Trial Info
Start Date :
December 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05196646
Start Date
December 5 2022
End Date
December 31 2025
Last Update
July 8 2025
Active Locations (1)
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1
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1