Ankyloglossia and Breastfeeding

NCT07757503 | Not Yet Recruiting

• 1 other identifier: 2025.16.EO
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankyloglossia; Breastfeeding

Keywords

Ankyloglossia; Tongue-tie; Breastfeeding; Breastfeeding effectiveness; TABBY Tongue-tie and Breastfed Babies; LATCH Breastfeediing assessment

Outcome Measures

Primary Outcomes (1)

• Beastfeeding effectiveness

  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

  During the first 72 hours of life.

Secondary Outcomes (5)

• Duration of exclusive breastfeeding assessed by maternal telephone interview

  From birth to 6 months of age

• Duration of any breastfeeding assessed by maternal telephone interview

  From birth to 6 months of age

• Maternal nipple pain assessed using the Numerical Rating Scale (NRS)

  During the first 72 hours after birth and at 5-15 days

• Breastfeeding outcomes after frenotomy assessed using the LATCH scale and maternal follow-up interviews

  From birth through 6 months of age

• Maternal satisfaction with breastfeeding assessed using a 0-to-5 numerical rating scale

  From birth to 6 months of age

Study Arms (2)

Newborn with ankyloglossia

Diagnostic Test: TABBY

Newborn without ankyloglossia

Interventions

TABBY DIAGNOSTIC_TEST

TABBY ≤ 5

Newborn with ankyloglossia

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ariana Muñoz San Miguel: lead

Study Sites (1)

University Hospital of Guadalajara

Guadalajara, Guadalajara, 19002, Spain

Location

Related Publications (5)

• Puapornpong P, Raungrongmorakot K, Mahasitthiwat V, Ketsuwan S. Comparisons of the latching on between newborns with tongue-tie and normal newborns. J Med Assoc Thai. 2014 Mar;97(3):255-9.

  PMID: 25123003 BACKGROUND

• Buryk M, Bloom D, Shope T. Efficacy of neonatal release of ankyloglossia: a randomized trial. Pediatrics. 2011 Aug;128(2):280-8. doi: 10.1542/peds.2011-0077. Epub 2011 Jul 18.

  PMID: 21768318 BACKGROUND

• Chinnadurai S, Francis DO, Epstein RA, Morad A, Kohanim S, McPheeters M. Treatment of ankyloglossia for reasons other than breastfeeding: a systematic review. Pediatrics. 2015 Jun;135(6):e1467-74. doi: 10.1542/peds.2015-0660. Epub 2015 May 4.

  PMID: 25941312 BACKGROUND

• O'Shea JE, Foster JP, O'Donnell CP, Breathnach D, Jacobs SE, Todd DA, Davis PG. Frenotomy for tongue-tie in newborn infants. Cochrane Database Syst Rev. 2017 Mar 11;3(3):CD011065. doi: 10.1002/14651858.CD011065.pub2.

  PMID: 28284020 BACKGROUND

• Ingram J, Johnson D, Copeland M, Churchill C, Taylor H, Emond A. The development of a tongue assessment tool to assist with tongue-tie identification. Arch Dis Child Fetal Neonatal Ed. 2015 Jul;100(4):F344-8. doi: 10.1136/archdischild-2014-307503. Epub 2015 Apr 15.

  PMID: 25877288 BACKGROUND

MeSH Terms

Conditions

Ankyloglossia; Breast Feeding

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Feeding Behavior; Behavior

Central Study Contacts

Ariana A Muñoz San Miguel, Midwife, PhD candidate

CONTACT

614609920; aams84@sescam.jccm.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Midwife, and PhD Candidate

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)