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Tongue-Tie treatment may help babies breastfeed better

NCT ID NCT05560750

Symptom relief Sponsor: University of Oulu Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looks at tongue-tie in newborns and whether treating it helps with breastfeeding. Researchers will follow 300 infants for up to 5 years, comparing different treatments. The goal is to make breastfeeding easier and less painful for mothers.

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 300 people

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

Started

Oct 2022

Expected to finish

Dec 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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Newborn infant with at tongue-tie interfering the breastfeeding and patient's study screening scoring exceeding \>8/19 Exclusion Criteria: * Child's severe anomaly or illness; the parent's severe illness; a communication problem between parents and researchers (e.g. language barrier); any other practical reason that prevents the child to have the procedure or the parents to provide the oral physiotherapy

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Conditions

The condition(s) this trial relates to.

ankyloglossia Breast Feeding

As listed by the trial registrant

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

Breast feeding Frenulum breve Frenulum; elongation Tongue-tie

Contacts and locations

Locations

  • Department of Otorhinolaryngology, Oulu University Hospital

    Oulu, Finland

  • Department of Pediatrics, Oulu University Hospital

    Oulu, Finland

  • University of Oulu, Faculty of Humanities, Research Unit of Logopedics

    Oulu, Finland

More trials for these conditions

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