Tongue-Tie and breastfeeding: a closer look at the first six months
NCT ID NCT07757503
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
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About 146 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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Up to 72 hours
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital of Guadalajara
Guadalajara, Guadalajara, 19002, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a wearable sensor read breast fullness and milk flow?
- What shapes breast milk? a deep dive into its composition
- Can a new device make Tongue-Tie release easier and gentler?
- Can a mediterranean diet lift postpartum depression?
- Could listening to success stories boost breastfeeding confidence?