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

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · Jan 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how well a new device can detect breathing sounds in preterm infants who are on a type of respiratory support called CPAP (Continuous Positive Airway Pressure). The goal is to see how accurately this device can monitor their breathing and identify any breathing problems, known as apnea of prematurity, which is common in babies born before 32 weeks of pregnancy. The researchers will be looking at 50 preterm infants in the neonatal intensive care unit (NICU) to see how effective this new method is compared to other monitoring techniques.

To be eligible for the study, infants must be born before 32 weeks of pregnancy and be between 28 and 36 weeks old at the time of the study. Some infants will need to be breathing on their own without any help, while others will be on CPAP support. Participants will be monitored using the new device, and their breathing will be assessed for any significant episodes that may require medical attention. This trial is important because it aims to improve how we monitor the breathing of fragile preterm infants, ensuring they receive the best possible care during their time in the NICU.

Gender

ALL

Eligibility 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.