Ankyloglossia and Breastfeeding

NCT07757503 · tracked via the Priya Life Science Spain tracker

Sponsor

Ariana Muñoz San Miguel

Phase

Observational

Started

2026-09

Last updated

2026-08-11

Condition(s) studied

AnkyloglossiaBreastfeeding

Investigational drug(s) / intervention(s)

TABBY

TABBY: TABBY ≤ 5

Study summary

Ankyloglossia is a congenital condition characterized by a restrictive lingual frenulum that may limit normal tongue mobility and be associated with breastfeeding difficulties. Reported problems include ineffective latch, maternal nipple pain and nipple trauma, mastitis, reduced milk transfer, poor infant weight gain, and early breastfeeding cessation. However, the available evidence regarding the impact of ankyloglossia on breastfeeding outcomes remains limited and controversial.

The primary objective of this prospective cohort study is to evaluate the association between neonatal ankyloglossia, assessed using the TABBY assessment tool during the first 72 hours of life, and breastfeeding effectiveness measured using the LATCH scale during the same period.

Mother-infant dyads will be recruited during the newborn's first 72 hours of life, during the hospital admission for childbirth, at the University Hospital of Guadalajara, Spain. Newborns will be classified according to the presence or absence of ankyloglossia using the TABBY assessment tool and will be followed for the first 6 months of life. Information will be collected during routine clinical follow-up and through telephone interviews.

The secondary objectives are to evaluate the association between ankyloglossia and breastfeeding duration, exclusive breastfeeding duration, maternal pain during breastfeeding, and maternal breastfeeding satisfaction.

Eligibility

Sex

ALL

Min age

—

Max age

72 Hours

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Beastfeeding effectiveness — During the first 72 hours of life.
Breastfeeding effectiveness assessed using the LATCH scale. LATCH (Latch, Audible swallowing, Type of nipple, Comfort, Hold).Breastfeeding effectiveness will be assessed using the LATCH scale. The scale evaluates five components: latch, audible swallowing, type of nipple, maternal breast and nipple comfort, and positioning assistance. Each component is scored from 0 to 2, giving a total score from 0 to 10. Higher scores indicate more effective breastfeeding

Trial sites (1)

Facility	City	Region	Status
University Hospital of Guadalajara	Guadalajara	Guadalajara

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Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07757503 on ClinicalTrials.gov ↗ ← All trials in Spain