Can reading a Preemie's cues speed up independent feeding?

NCT ID NCT06569186

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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
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 Results may not be published yet.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 This study
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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This pilot trial tests whether feeding very low birthweight infants based on their own hunger and fullness cues helps them transition from tube to bottle or breast feeding faster than the standard clinician-driven approach. Researchers will randomly assign infants to either cue-based feeding, guided by speech therapists and nurses, or clinician-driven feeding, where doctors set the feeding plan. The main goal is to measure the time from starting oral feeding to achieving independent feeding, with secondary measures including hospital stay length and weight gain.

What this could mean

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

Active substance
Cue-based feeding, a behavioral intervention where speech therapists and nurses use infant hunger and fullness cues to guide oral feeding
What this could lead to
If cue-based feeding helps very low birthweight infants reach independent oral feeding sooner, it could shorten hospital stays and improve feeding outcomes for this vulnerable group.
What could go wrong
This is a small pilot study, so results may not be definitive or apply broadly. The intervention depends on staff training and consistency, which could vary.

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.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Oct 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.

Ages

28 to 32 weeks

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: * Birthweight \< 1500 grams * Gestational age between 28 and 31 weeks of gestation * Full enteral feeding established before 32 weeks of postmenstrual age (PMA) * Oral feeding initiated before 33 weeks PMA. Exclusion criteria: * Major congenital/chromosomal anomalies, * Patent ductus arteriosus causing significant cardiovascular symptoms * History of necrotizing enterocolitis stage 2 or greater

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Conditions

The condition(s) this trial relates to.

Feeding Behavior

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

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