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Simple mouth exercises may help tiny preemies feed and grow faster

NCT ID NCT07366190

Symptom relief Sponsor: Necmettin Erbakan University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a gentle mouth exercise program called PIOMI on preterm babies born between 26 and 30 weeks. Half of the 32 babies received the exercises twice daily for a week, while the other half got standard care. Researchers looked at whether the exercises improved breastfeeding, weight gain, and how long babies stayed in the hospital.

What this could mean

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

Active substance
Premature Infant Oral Motor Intervention (PIOMI) - a series of gentle mouth exercises
What this could lead to
If it works, this simple exercise program could help preterm babies feed better, gain weight faster, and leave the hospital sooner.
What could go wrong
This is a very small, early study with only 16 babies per group. Results may not apply to all preterm infants, and the exercises may not work for every baby.

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

16 people

The number who actually took part.

Started

Dec 2024

Finished

Jul 2025

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

24 to 30 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: * Gestational age between 26 and 30 weeks, * Minimum birth weight of 1350 grams, * Physical stability during oral stimulation, * Apgar score of 4 or above at 5 minutes after birth. Exclusion Criteria: * Presence of congenital anomalies or chromosomal abnormalities, * Chronic medical conditions such as bronchopulmonary dysplasia, * Intraventricular hemorrhage (Grade III or IV), * Necrotizing enterocolitis (NEC), * Asphyxia and seizures, * Treatments related to neonatal jaundice requiring exchange transfusion or blood transfusion, * Sepsis confirmed by positive blood culture.

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Conditions

The condition(s) this trial relates to.

Premature Birth Weight Gain

As listed by the trial registrant

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

Prematurity

Contacts and locations

Locations

  • Necmettin Erbakan University

    Konya, Konya, 40336, Turkey (Türkiye)

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Other studies related to the condition(s) this trial covers.