Monitoring breathing events in preterm infants using sound technology
Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on Continuous Positive Airway Pressure: the DREAM Pilot Project
This study is testing a new sound technology to see if it can help monitor breathing in preterm infants on CPAP better than traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 72 Hours and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05196646 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility of using a novel respiratory acoustic sensor to monitor breathing sounds in preterm infants on CPAP. It will recruit 50 infants with a gestational age of less than 32 weeks from the neonatal intensive care unit at the Montreal Children's Hospital. The study will compare the new acoustic monitoring method with traditional techniques like transthoracic impedance and respiratory inductive plethysmography to evaluate its accuracy in detecting respiratory efforts and cardiorespiratory events. The goal is to improve the understanding and differentiation of apnea and other respiratory issues in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants with a gestational age of less than 32 weeks who are receiving CPAP support.
Not a fit: Patients with major congenital abnormalities, congenital heart disorders, or those requiring inotropic or sedative agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate monitoring of breathing events in preterm infants, potentially reducing complications associated with apnea of prematurity.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using acoustic monitoring for respiratory events, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montreal, Quebec
- McGill University Health Center — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Wissam M Shalish, MD PhD — McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study coordinator: Wissam M Shalish, MD PhD
- Email: wissam.shalish@mcgill.ca
- Phone: 514-412-4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.