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New sound sensor could help preterm babies breathe easier

NCT ID NCT05196646

Knowledge-focused Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new, non-invasive device that listens to the breathing sounds of preterm babies to detect breathing pauses and heart rate changes. Researchers will enroll 50 preterm infants born before 32 weeks to see if the acoustic sensor can reliably monitor breathing compared to standard methods. The goal is to improve early detection of breathing problems in the NICU without disturbing the baby.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital.

Ages

72 hours and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Apnea apnea of prematurity Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Apnea of prematurity

Contacts and locations

Locations

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1, Canada

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Other studies related to the condition(s) this trial covers.