About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TABBY
Treatment groups
Sponsors and collaborators
Ariana Muñoz San Miguel
Lead sponsor
University of Alcala
Sponsor institution