Clinical Trial

Ankyloglossia and Breastfeeding

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07757503
Lead Sponsor Ariana Muñoz San Miguel
Conditions Ankyloglossia, Breastfeeding
Enrollment 146 participants
Start Date 2026-09
Primary Completion 2028-06 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-11