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A simple tool may help preemies eat faster and leave the NICU sooner

NCT ID NCT07136610

Disease control Sponsor: Wake Forest University Health Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This study tests whether a standardized feeding assessment tool, called the SMART Tool, can help premature and medically complex infants develop oral feeding skills more quickly. The tool is being integrated into hospital electronic records, and all NICU staff are being trained to use it. Researchers want to see if this leads to fewer days on tube feeding, shorter hospital stays, and safer feedings for thousands of infants.

What this could mean

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

Active substance
SMART Tool feeding skill assessment integrated into electronic health records with staff training
What this could lead to
If successful, this tool could help premature infants develop feeding skills faster, shorten hospital stays, and reduce stress for families.
What could go wrong
This is an implementation study, not a drug trial, so results depend on staff adoption and consistency. The tool may not improve outcomes for all infants.

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 3,500 people

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

Started

Aug 2025

Expected to finish

Jul 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 1 year

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 born between August 1, 2025, and July 31, 2026, AND admitted to NICU Exclusion Criteria: * No oral feeding started by July 15, 2026

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Conditions

The condition(s) this trial relates to.

Breast Feeding Premature Birth

As listed by the trial registrant

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

Infant and young child feeding

How to take part

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

  1. The places running it

    14 sites. 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

  • Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn)

    RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • Advocate Condell Medical Center

    RECRUITING

    Libertyville, Illinois, 60048, United States

  • Advocate Good Shepherd Hospital

    RECRUITING

    Barrington, Illinois, 60010, United States

  • Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge)

    RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Advocate Sherman Hospital

    RECRUITING

    Elgin, Illinois, 60123, United States

  • Advocate Trinity Hospital

    RECRUITING

    Chicago, Illinois, 60617, United States

  • Aurora BayCare Medical Center

    RECRUITING

    Green Bay, Wisconsin, 54311, United States

  • Aurora Medical Center - Sheboygan County

    RECRUITING

    Sheboygan, Wisconsin, 53081, United States

  • Aurora Medical Center - Summit

    RECRUITING

    Summit, Wisconsin, 53066, United States

  • Aurora Medical Center Grafton

    RECRUITING

    Grafton, Wisconsin, 53024, United States

  • Aurora Medical Center Kenosha

    RECRUITING

    Kenosha, Wisconsin, 53142, United States

  • Aurora Medical Center Oshkosh

    RECRUITING

    Oshkosh, Wisconsin, 54904, United States

  • Aurora Sinai Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53233, United States

  • Aurora West Allis Medical Center

    RECRUITING

    West Allis, Wisconsin, 53227, United States

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