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 range72 Hours

SexALL

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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.

What they're measuring

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-28