Ireland
--:--IST
Recruiting Observational

Acoustics as a Metric of Airway Pressure in Premature Infants Using Bubble Continuous Positive Airway Pressure

NCT07060833 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2025-04-03
Last updated
2026-03-30

Condition(s) studied

Preterm Infant

Investigational drug(s) / intervention(s)

External pressure transducerStandard microphoneWireless acoustic sensorInternal pressure transducer

External pressure transducer: The delivered CPAP pressure will be measured using an ultra-thin, multi-use catheter pressure transducer inserted into a port in the expiratory limb of the bubble CPAP circuit.

Standard microphone: The bubble sound of the water tank will be collected with a standard condenser microphone directly affixed to the pole holding the water tank, with a secure clip.

Wireless acoustic sensor: The wireless acoustic sensor contains a dual microphone capable of capturing target sounds as well as ambient noise. The frequencies associated with ambient noise will be subtracted to maximize the signal-to-noise ratio of the bubble sound waveform. The wireless sensor will be placed on the suprasternal notch of the infant for monitoring the bubble sounds transmitted to the lungs and secured using a silicone-based tape approved for use in neonates. Data will be transmitted in real-time to a research-dedicated tablet using the Bluetooth Communication Controller and stored for future analysis.

Internal pressure transducer: The transmitted CPAP pressure will be measured using an ultra-thin, single-use catheter pressure transducer inserted through the mouth to the level of the infant's nasopharynx. The data will be acquired with a sampling rate of 10kHz and stored for later analysis.

Study summary

This is an observational, proof-of-concept, feasibility study where 30 preterm infants on bubble CPAP 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 main goals are:

1. To determine the relationship between ambient bubbling sounds and delivered pressures in preterm infants on bCPAP.
2. To determine the relationship between transmitted bubbling sounds and airway pressures transmitted to the lungs of preterm infants on bCPAP.
3. To develop models to predict delivered and transmitted bCPAP pressures from the acoustic properties of bubbling sounds.

Eligibility

Sex
ALL
Min age
28 Weeks
Max age
32 Weeks
Healthy volunteers
No
Inclusion Criteria: * Infants on bCPAP with gestational age \< 32+0 weeks * Postmenstrual age between 28+0 and 36+6 weeks at the time of the study * Postnatal age greater than 168 hours (7 days) at the time of the study * On the bubble CPAP device with binasal prongs at the time of the study * Receiving bubble CPAP levels of 5 to 7 cm H2O with gas flows between 6L/min and 10L/min at the time of the study Exclusion Criteria: * Infants with known major congenital anomalies * Infants with known congenital heart disorders * Infants with known neuromuscular disease * Infants receiving ventilator-derived CPAP at the time of the study * Infants receiving CPAP via a nasal mask interface at the time of the study * Infants receiving inotropes, narcotics or sedative agents at the time of the study * Infants deemed clinically unstable for the study by the attending neonatologist

Primary outcome measure(s)

  • Pressure — 3 hours
    The mean pressure and the standard deviation of the pressure will be computed for each segment.
  • External bubble CPAP sounds — 3 hours
    Two metrics will be computed: 1. The root mean square (RMS) 2. The power contained between a pre-determined range within each segment; We will determine the range that contains 80% of the signal power, in order to minimize other noises from bubble CPAP signal.
  • Internal bubble CPAP sounds — 3 hours
    1. We will apply biomedical signal processing methods to separate the bubbling sounds from breathing sounds. Then, RMS and power will be computed. 2. We will use the Pearson correlation coefficient to compute the relationship between bubbling sound and pressure metrics. We will evaluate the linear regression models to identify the combination of sound metrics and covariates with the highest predictive accuracy.

Trial sites (1)

FacilityCityRegionStatus
McGill University Health Center Montreal Quebec Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07060833 on ClinicalTrials.gov ↗ ← All trials in Canada