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Smart belt could save newborns from silent danger

NCT ID NCT07213401

Prevention Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a soft belt that tracks a newborn's heart rate and breathing during the first few days of life. The goal is to catch early signs of sudden unexpected postnatal collapse (SUPC), a rare but serious event. Researchers will enroll 5,000 babies to see if the device detects warning signs that routine checks miss.

What this could mean

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

Active substance
ComfTech HOWDY BABY wearable monitoring belt
What this could lead to
If successful, this device could help prevent sudden unexpected postnatal collapse in newborns by catching early warning signs like slow heart rate or breathing pauses.
What could go wrong
This is an early-stage study with no results yet. The device may not reliably detect all warning events, and false alarms could cause unnecessary worry.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 5,000 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Jun 2027

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.

Ages

Up to 3 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Gestational age ³ 35 weeks * Apgar score at 5 minutes ³ 8 * Acquisition of written informed consent from the parent/guardian Exclusion Criteria: * Major congenital malformations * Family history of silver allergy

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As listed by the trial registrant

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

Sudden unexpected postnatal collapse -supc

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

  • Irccs Aoubo

    Bologna, BO, 40131, Italy