An observational study in Ankyloglossia and Breastfeeding, sponsored by Ariana Muñoz San Miguel. Not yet recruiting at 1 site in Spain. Open to participants aged Up to 72 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Ariana Muñoz San Miguel · Observational
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.
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.
32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: TABBY
TABBY ≤ 5
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
Time frame: During the first 72 hours of life.
Duration of exclusive breastfeeding assessed by maternal telephone interview
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.
Time frame: From birth to 6 months of age
Duration of any breastfeeding assessed by maternal telephone interview
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.
Time frame: From birth to 6 months of age
Maternal nipple pain assessed using the Numerical Rating Scale (NRS)
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.
Time frame: 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
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.
Time frame: From birth through 6 months of age
Maternal satisfaction with breastfeeding assessed using a 0-to-5 numerical rating scale
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.
Time frame: From birth to 6 months of age
Plan to share: No
Start is estimated for Sep 2026; primary completion for Jun 2028, 21 months later.
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