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Baby monitor trial aims to slash ER visits for NICU grads

NCT ID NCT06565390

Disease control Sponsor: University of Alabama at Birmingham 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving high-risk infants an Owlet smart sock monitor after NICU discharge can reduce emergency room visits and hospital readmissions. The device tracks heart rate and oxygen levels and alerts caregivers to problems. 700 babies will be enrolled to see if remote monitoring helps keep them safer at home.

What this could mean

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

Active substance
Owlet OSS 3.0 pulse oximeter (device)
What this could lead to
If it works, this could reduce emergency room visits and hospital readmissions for high-risk infants after NICU discharge, improving outcomes and lowering healthcare costs.
What could go wrong
This is a relatively early-stage trial with 700 participants, and the device may cause false alarms or caregiver anxiety. It may not significantly reduce ER visits or rehospitalizations.

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 700 people

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

Started

Sep 2025

Expected to finish

Dec 2030

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

22 weeks to 6 months

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: * Infants being discharged from the NICU * Off all respiratory support (oxygen, CPAP, ventilator) before discharge home * Gestational age ≥ 22 0/7 weeks' gestation at birth * Parents/legal guardians have provided consent for enrollment Exclusion Criteria: * a major malformation, a neuromuscular condition that affects respiration or causes apnea, complex congenital heart disease and hemodynamically significant shunts, or terminal illness or decision to withhold or limit support. * Infants being discharged from the neonatal intensive care unit (NICU) with a cardiorespiratory monitor or respiratory support are not eligible for inclusion.

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Conditions

The condition(s) this trial relates to.

Emergencies

As listed by the trial registrant

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

Emergencies

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

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35249, United States

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