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

Status: Active_not_recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 days
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
McGill University Health Center
Montreal
Time Frame
Start Date: 2022-12-05
Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
(1) 10 preterm infants spontaneously breathing in-room air with no respiratory support
Group 1 will consist of 10 preterm infants spontaneously breathing in room air, with no respiratory support, in whom respiratory acoustic signals from the acoustic sensor will be compared with airflow measurements obtained using a pneumotachometer, i.e. the gold standard. Data will be acquired for 10 minutes.
(2) 20 preterm infants spontaneously breathing in-room air with no respiratory support
Group 2 will consist of 20 preterm infants spontaneously breathing in room air, with no respiratory support, in whom respiratory acoustic signals from the acoustic sensor will be compared with airflow measurements obtained using a nasal temperature sensor. In addition, measurements of respiratory efforts will be obtained using the Respiratory Inductance Plethysmography (RIP), an inertial measurement unit (IMU) integrated within the acoustic sensor, and the Transthoracic Impedance (TTI) from the bedside monitor. Data will be continuously recorded for 3 hours.
(3) 20 preterm infants on continuous positive airway pressure (CPAP) with cardiorespiratory events
Group 3 will consist of 10 preterm infants on CPAP with established cardiorespiratory events, in whom respiratory acoustic signals from the acoustic sensor will be continuously measured for 3 hours. In addition, measurements of respiratory efforts will be obtained using the Respiratory Inductance Plethysmography (RIP), an inertial measurement unit (IMU) integrated within the acoustic sensor, and the Transthoracic Impedance (TTI). Data will be continuously recorded for 3 hours.
Related Therapeutic Areas
Sponsors
Collaborators: Northwestern University
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov