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A lullaby pacifier may teach preemies to eat

NCT ID NCT07819734

Symptom relief Sponsor: Nemours Children's Clinic Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

Preterm infants often struggle to feed by mouth because the coordination of sucking, swallowing, and breathing develops late in pregnancy. Researchers at Nemours Children's Hospital in Orlando tested a pacifier that plays a recorded caregiver's voice when an infant sucks hard enough, aiming to reinforce the sucking motion. In a randomized trial, 46 preterm infants moving from tube feeding to oral feeding received either this pacifier therapy plus standard care or standard care alone. The team compared how much milk infants took in, how quickly they fed, their weight gain, and how many days they needed tube feeding.

What this could mean

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

Active substance
a pacifier-activated lullaby device that plays a recorded caregiver voice when a preterm infant sucks
What this could lead to
If it works, this could give neonatal units a simple, low-risk way to help preterm infants learn to feed by mouth and go home sooner.
What could go wrong
The trial is small, with 46 infants at one hospital, so any benefit may be modest or may not hold in other nurseries. The device only adds sound to standard feeding care, and some infants may not respond to it.

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 46 people

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

Started

Nov 2020

Expected to finish

Mar 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

34 to 36 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: * Preterm infants born at less than 32 weeks gestational age * Postmenstrual age between 34 0/7 and 35 6/7 weeks at enrollment * Receiving at least half of nutritional intake enterally and less than half orally * Written informed consent obtained from parent(s) or legal guardian(s) Exclusion Criteria: * Mechanical ventilation at enrollment * Continuous positive airway pressure (CPAP) support * High-flow nasal cannula support \>2 L/min * Determined by the treating medical team to be unsafe for oral feeding * Determined by feeding or speech specialists to be unsafe for oral feeding * Clinical instability preventing participation in study procedures

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Dysphagia of newborn

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Nemours Children's Hospital, Florida

    RECRUITING

    Orlando, Florida, 32827, United States