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Tongue-Tie and breastfeeding: a closer look at the first six months

NCT ID NCT07757503

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This study follows about 146 mother-infant pairs to see if tongue-tie (ankyloglossia) affects how well breastfeeding goes. Newborns are checked for tongue-tie within their first 72 hours using the TABBY tool, and breastfeeding effectiveness is measured with the LATCH scale. The researchers also track how long mothers breastfeed, any pain they feel, and their satisfaction over the first six months. The goal is to better understand the real impact of tongue-tie on breastfeeding.

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 a clear link is found, it could guide earlier screening and support for tongue-tie in newborns, potentially improving breastfeeding outcomes.
What could go wrong
This is an observational study, so it can show associations but not prove cause and effect. Results may be influenced by other factors and may not apply to all populations.

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 146 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

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

The study population will consist of mother-infant dyads recruited during the newborn's first 72 hours of life, during the hospital admission for childbirth at the University Hospital of Guadalajara (Spain). Eligible newborns will be healthy, singleton, term infants (37 weeks to 41 weeks and 6 days of gestation). Participants will be classified according to the presence or absence of ankyloglossia based on the TABBY assessment tool and followed for 6 months.

Ages

Up to 72 hours

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: * Mother-infant dyads recruited during the newborn's first 72 hours of life, during the hospital admission for childbirth at the University Hospital of Guadalajara. * Singleton pregnancy. * Gestational age at birth between 37 weeks and 41 weeks and 6 days. * Maternal intention to provide exclusive or mixed breastfeeding. * Written informed consent provided by the parent or legal guardian. Exclusion Criteria: * Birth outside the University Hospital of Guadalajara. * Preterm birth (\<37 weeks of gestation). * Fetal or neonatal pathology diagnosed before or after birth. * Admission to the neonatal unit after birth or during the hospital stay. * Any contraindication to breastfeeding. * Language barriers preventing communication in Spanish with the parents or legal guardians. * Withdrawal of informed consent. * Loss to follow-up.

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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.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University Hospital of Guadalajara

    Guadalajara, Guadalajara, 19002, Spain

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