Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP — DREAM  

Apnea of Prematurity Clinical Trial

Official title: Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on Continuous Positive Airway Pressure: the DREAM Pilot Project

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. Unfortunately, the current standard for monitoring cardiorespiratory events in the NICU, transthoracic impedance (TTI), does not permit for accurate differentiation of the different types of cardiorespiratory events; TTI cannot detect airflow and has low accuracy for detecting respiratory efforts. As a result, TTI does not detect obstructive apneas and may not reliably capture all central apneas.

Respiratory sounds are an attractive surrogate measure of airflow, and can be captured using respiratory acoustic technology (akin to a miniaturized electronic stethoscope). We hypothesize that respiratory acoustic monitoring can provide a continuous, non-invasive, and accurate representation of airflow and breathing sounds in preterm infants.

Altogether, we conjecture that the combination of respiratory acoustic monitoring with measurements of respiratory effort will improve the ability to differentiate and describe the nature of cardiorespiratory events in preterm infants. ;

Related Conditions & MeSH terms

• Apnea of Prematurity
• Premature Birth

• NCT number: NCT05196646
• Study type: Observational
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Wissam M Shalish, MD PhD
• Phone: 514-412-4400
• Email: wissam.shalish@mcgill.ca
• Status: Recruiting
• Start date: December 5, 2022
• Completion date: July 30, 2024