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Tongue-Tie study aims to settle breastfeeding debate

NCT ID NCT07512765

Knowledge-focused Sponsor: Erasme University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 348 infants from birth to age 4 to see how tongue-tie (a tight piece of skin under the tongue) affects breastfeeding, feeding, and speech. Researchers will measure tongue movement and compare different ways to diagnose the condition. The goal is to provide clear evidence to help parents and doctors decide whether a simple snip (frenotomy) is needed.

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

348 people

The number who actually took part.

Started

May 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.

Who is studied

Healthy newborns at the maternity ward of Erasme Hospital, Anderlecht, born between 23/05/2022 and 30/09/2024.

Ages

1 day to 5 days

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: * Newborn infant with a gestational age ≥ 37 weeks admitted to the postnatal ward of Hospital Erasmus- 1 to 5 days old * Mother intends to breastfeed at the postnatal ward * At least one parent has a good understanding of French Exclusion Criteria: Newborns will be excluded from the study if they present any of the following: * Severe medical conditions, including congenital oropharyngeal malformations (e.g. cleft lip, heart defects or brain anomalies) or Prader-Willi syndrome, sepsis, intrauterine growth restriction, need for intensive care * A positive COVID-19 test (for either the newborn or parents) * Multiple births (twins, triplets) * Parents under psychosocial surveillance

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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.

Ankyloglossia Breastfeeding Breastfeeding duration Breastfeeding outcomes Breastfeeding self-efficacy

Contacts and locations

Locations

  • Hopital Erasme

    Brussels, Anderlecht, 1070, Belgium

More trials for these conditions

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