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Could a simple, Low-Cost device help detect when infants stop breathing?

NCT ID NCT07704320

Disease control Sponsor: William Marsh Rice University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This trial evaluates a device called BreathAlert, a low-cost, battery-powered monitor designed to detect breathing and alert caregivers when an infant stops breathing (apnea). Researchers are testing it in infants at risk for apnea in a hospital setting, comparing its accuracy to standard vital sign monitors. The goal is to see if BreathAlert can reliably track breathing and spot apneic episodes, potentially offering an affordable monitoring option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BreathAlert device (low-cost respiratory rate and apnea monitor)
What this could lead to
If successful, BreathAlert could provide an affordable, reliable way to monitor breathing in infants, potentially reducing apnea-related complications in low-resource settings.
What could go wrong
This is a small pilot study, so results may not confirm accuracy or generalizability. The device may not perform as well as standard monitors in all situations.

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 60 people

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

Started

Mar 2017

Expected to finish

Jun 2028

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

Patients in the neonatal or pediatric ward deemed to be at risk for apnea or in need of respiratory rate monitoring

Ages

0 to 17 years

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: * Participants will be identified using the eligibility criteria stipulated below. 1. The patient is currently being treated at QECH in the neonatal or pediatric ward. 2. The patient is deemed to be at risk for apnea or in need of respiratory rate monitoring. 3. A BreathAlert device is available for use while the patient is at risk for apnea. 4. The patient's caregiver has provided informed consent for their child to participate. Exclusion Criteria:

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Conditions

The condition(s) this trial relates to.

infantile apnea

As listed by the trial registrant

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

Apnea infant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Queen Elizabeth Central Hospital

    RECRUITING

    Blantyre, Malawi