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Cheek muscle thickness may predict feeding success in preemies

NCT ID NCT07656467

Knowledge-focused Sponsor: Polish Mother Memorial Hospital Research Institute Source: ClinicalTrials.gov ↗

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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 This study
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 Results may not be published yet.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)
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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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study looks at whether the thickness of the masseter (cheek) muscle affects how premature babies learn to feed by mouth. Researchers will use ultrasound to measure the muscle and observe feeding sessions in 30 infants born between 28 and 32 weeks. The goal is to understand feeding development better, which could help improve care in neonatal units.

What this could mean

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

What this could lead to
If successful, this could help doctors better understand feeding difficulties in premature babies and improve care in neonatal units.
What could go wrong
This is a small, early observational study with only 30 infants. It does not test a treatment, so results may not lead to direct changes in care.

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.

Participants

About 30 people

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

Started

Jun 2026

Expected to finish

Dec 2029

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.

Who is studied

The study will include premature newborns hospitalized in the Neonatology, Intensive Care and Neonatal Pathology Clinic, Polish Mother's Memorial Hospital Research Institute, Łódź, Poland

Ages

28 to 32 weeks

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: * 28+0/7-32+0/7 weeks of gestational age; * use of one specific type of teat; * passive oxygen therapy is permitted; * written informed consent obtained from parents. Exclusion Criteria: * newborns with defects that may significantly affect the development of feeding function such as: cleft lip and/or palate, facial paralysis, and other craniofacial defects; * newborns with a shortened anterior lingual frenulum according to the E. Coryllos classification - meeting the criteria for frenotomy according to the Hazelbaker/Amir scale; * detected genetic defects, metabolic diseases, or suspected cases of their presence; * newborns requiring intubation up to 10 days of life; * low Apgar score (less than 5 points at 5 and 10 minutes of life); * newborns with visible neurological disorders (e.g. with symptoms of hypertonia, impaired reflex reactions in the orofacial area) and/or significant abnormalities in central nervous system (CNS) imaging studies (e.g. III-IV degree intraventricular hemorrhages, CNS defects, hydrocephalus); * newborns of mothers with anhydramnios; * lack of consent to conduct at least two bottle-feeding sessions; * a child fed with a different type of teat than the one used in the study.

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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.

Premature infants

How to take part

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  1. The places running it

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  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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Contacts and locations

Locations

  • Polish Mother's Memorial Hospital - Research Institute

    Lodz, Łódź Voivodeship, 93-338, Poland

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