Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP (NCT05196646) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP
Canada50 participantsStarted 2022-12-05
Plain-language 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 Children's Hospital.
The study's primary objective is to describe the relationship between respiratory acoustics and airflow and determine the reliability of a novel respiratory acoustic sensor at detecting breathing sounds in preterm infants.
The study's secondary objectives are:
1. To compare transthoracic impedance, respiratory inductive plethysmography and an inertial measurement unit for the detection of respiratory efforts in preterm infants.
2. To evaluate the feasibility and accuracy of a novel, non-invasive method for continuously detecting and differentiating cardiorespiratory events in preterm infants on CPAP by integrating measurements of respiratory effort with respiratory acoustic monitoring.
Who can participate
Age range
72 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reliability of respiratory acoustics at detecting airflow compared to airflow measurements obtained from a pneumotachometer.
Timeframe: 10 minutes (group 1) or 3 hours (groups 2 and 3)
Trial details
NCT IDNCT05196646
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre