AnkyloglossiaNCT07757503
Ankyloglossia and Breastfeeding
An observational study of Ankyloglossia and Breastfeeding, run by Ariana Muñoz San Miguel at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Ankyloglossia, Breastfeeding
- What is being tested?
- TABBY
- How many people
- 146 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: THE EFFECT OF ANKYLOGLOSIA ON BREASTFEEDING: A COHORT STUDY
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Ankyloglossia, Breastfeeding
- Being tested
- TABBY
- Keywords
- Ankyloglossia, Tongue-tie, Breastfeeding, Breastfeeding effectiveness, TABBY Tongue-tie and Breastfed Babies, LATCH Breastfeediing assessment
- Medical subject headings
- Ankyloglossia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TABBYDiagnostic test
TABBY ≤ 5
| Study group | Role | What they receive |
|---|---|---|
| Newborn with ankyloglossia | Not described Receives: Diagnostic Test: TABBY | |
| Newborn without ankyloglossia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the first 72 hours of life.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From birth to 6 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnkyloglossiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ariana Muñoz San Miguel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ariana Muñoz San Miguel, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757503
- Sponsor's protocol ID
- 2025.16.EO
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25123003Buryk 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.
PubMed 21768318Chinnadurai 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.
PubMed 25941312O'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.
PubMed 28284020Ingram 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.
PubMed 25877288
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF ANKYLOGLOSIA ON BREASTFEEDING: A COHORT STUDY
- ClinicalTrials.gov ID
- NCT07757503
- Acronym / sponsor ID
- 2025.16.EO
- Conditions
- Ankyloglossia, Breastfeeding
- Keywords
- Ankyloglossia, Tongue-tie, Breastfeeding, Breastfeeding effectiveness, TABBY Tongue-tie and Breastfed Babies, LATCH Breastfeediing assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Ariana Muñoz San MiguelUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newborn with ankyloglossia | – | Diagnostic Test: TABBY |
| Newborn without ankyloglossia | – | – |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TABBYTABBY ≤ 5 | Diagnostic test | Newborn with ankyloglossia |
Primary outcome
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
5 secondary outcomes
Duration of exclusive breastfeeding assessed by maternal telephone interview
Time frame: From birth to 6 months of age
Duration of any breastfeeding assessed by maternal telephone interview
Time frame: From birth to 6 months of age
Maternal nipple pain assessed using the Numerical Rating Scale (NRS)
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
Time frame: From birth through 6 months of age
Maternal satisfaction with breastfeeding assessed using a 0-to-5 numerical rating scale
Time frame: From birth to 6 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 25123003Puapornpong 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.
- Background: PubMed 21768318Buryk 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.
- Background: PubMed 25941312Chinnadurai 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.
- Background: PubMed 28284020O'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.
- Background: PubMed 25877288Ingram 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.
- Individual participant dataSharing planned: No
Related trials for Ankyloglossia
Not yet recruiting
Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise
Ankyloglossia, Impairment of Speech
Enrolling by invitationObservational study
Long-term Follow-up of Infant Frenotomy/Frenectomy Through Early Childhood
Ankyloglossia
Not yet recruiting
SNIP follow-on Case Series Using v3 Device
Ankyloglossia
Recruiting
The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes
Ankyloglossia
Active, not recruiting
Case Series of Infants With Anterior Ankyloglossia Being Treated by the Sublingual Neonatal Incision Platform Device
Ankyloglossia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankyloglossia and Breastfeeding, run by Ariana Muñoz San Miguel at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariana A Muñoz San Miguel, Midwife, PhD candidate (614609920, aams84@sescam.jccm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beastfeeding effectiveness (time frame: During the first 72 hours of life.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07757503, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.