RecruitingNCT07060833

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

The Use of Bubble Continuous Positive Airway Pressure in Premature Infants: Acoustics as a Metric of Effective Pressure Delivery

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

30 participants

Start Date

Apr 3, 2025

Study Type

OBSERVATIONAL

Conditions

Preterm infant

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

Min Age: 28 WeeksMax Age: 32 Weeks

Inclusion Criteria5

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 Criteria7

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEExternal 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.

DEVICEStandard 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.

DEVICEWireless 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.

DEVICEInternal 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.