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NCT Number: NCT07757503

Ankyloglossia and Breastfeeding

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.

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Key information

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Guadalajara

Guadalajara, 19002, Spain

About this study

A prospective observational cohort study will be conducted. 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.

The presence of ankyloglossia will be assessed using the TABBY tool during the first 72 hours of life. Newborns will be classified into two cohorts according to the presence or absence of ankyloglossia. The planned sample size is 146 mother-infant dyads: 73 newborns with ankyloglossia and 73 newborns without ankyloglossia.

Non-probability consecutive sampling will be used. For each newborn with ankyloglossia included in the study, one newborn without ankyloglossia will be selected from among the next newborns assessed who meet the inclusion criteria and whose parents provide informed consent.

The study will not assign interventions or modify routine clinical care. The performance of frenotomy and the provision of individual breastfeeding counselling will depend on the clinical assessment and the decisions made by the healthcare professionals responsible for the participants' care. These procedures will be recorded to analyse their possible association with breastfeeding outcomes.

The initial assessment of ankyloglossia using TABBY and breastfeeding effectiveness using LATCH will be performed during the first 72 hours of life. The dyads will be followed up between 5 and 15 days, between 30 and 40 days, and at 4 and 6 months of life. Information will be obtained from clinical assessments, electronic health records and, when necessary, telephone interviews.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TABBY

Diagnostic Test

TABBY ≤ 5

Primary outcomes

  1. Beastfeeding effectiveness

    Time frame: 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

Secondary outcomes

  1. Duration of exclusive breastfeeding assessed by maternal telephone interview

    Time frame: From birth to 6 months of age

    Duration of exclusive breastfeeding will be determined through maternal telephone interviews conducted at 4 and 6 months. It will be measured as the time from birth until the introduction of infant formula, other liquids, or complementary foods.

  2. Duration of any breastfeeding assessed by maternal telephone interview

    Time frame: From birth to 6 months of age

    Duration of any breastfeeding will be determined through maternal telephone interviews conducted at 4 and 6 months. It will be measured as the time from birth until complete cessation of breastfeeding, regardless of the introduction of infant formula, other liquids, or complementary foods.

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

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

    Maternal nipple pain during breastfeeding will be assessed using the Numerical Rating Scale (NRS). Mothers will rate their pain from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.

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

    Time frame: From birth through 6 months of age

    Among infants with ankyloglossia, breastfeeding outcomes will be compared between those who undergo frenotomy as part of routine clinical care and those who do not. Outcomes will include duration of any breastfeeding, duration of exclusive breastfeeding, maternal pain during breastfeeding, and maternal satisfaction with breastfeeding measured on a numerical rating scale from 0 to 5. Data will be collected through scheduled maternal follow-up interviews. The study will not assign frenotomy.

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

    Time frame: From birth to 6 months of age

    Maternal satisfaction with breastfeeding will be assessed using a numerical rating scale ranging from 0 to 5, where 0 indicates no satisfaction and 5 indicates the highest possible satisfaction. Higher scores indicate greater maternal satisfaction with breastfeeding.

Study contacts

Contact information is provided by the study sponsor or research team.

Ariana A Muñoz San Miguel, Midwife, PhD candidate

CONTACT

[email protected]

614609920

Sponsors and collaborators

Lead sponsor

Ariana Muñoz San Miguel

Other

Registry information

Official study title

THE EFFECT OF ANKYLOGLOSIA ON BREASTFEEDING: A COHORT STUDY

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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