Ankyloglossia and Its Effects on Breastfeeding, Feeding and Speech Disorders. A Prospective Study From Birth to 4 Years of Age. (ANK-PROS)

The diagnosis of ankyloglossia (restrictive lingual frenulum) and the number of frenotomies in infants have sharply increased, raising concerns among the medical community and the ONE. While some studies suggest benefits of frenotomy on breastfeeding, all emphasize the lack of consensus regarding the definition, diagnosis, and classification of ankyloglossia, as well as the scarcity of prospective data on its impact on breastfeeding, feeding, occlusion, and speech.

This prospective study aims to determine whether lingual frenulum characteristics influence early breastfeeding difficulties and duration, as well as later feeding, occlusion, and speech outcomes. Breastfed newborns are followed from the first days of life (T1) to age 4 years (T7). During the first 3 months, tongue mobility, frenulum characteristics, breastfeeding, maternal pain, and complications are assessed. Several clinical tools are compared to identify the most reliable ones. Frenulum length is measured using calibrated photographs.

Phone follow-ups at 6 months, 1 and 2 years assess feeding outcomes; speech and occlusion are evaluated at 4 years.

This project could provide objective data to guide clinicians in evaluating ankyloglossia and making informed frenotomy decisions, improve breastfeeding support, and help parents make evidence-based choices.

Study Overview

• Status: Active, not recruiting
• Conditions: Breastfeeding; Breastfeeding Outcomes; Ankyloglossia; Breastfeeding Duration; Breastfeeding Self-Efficacy
• Intervention / Treatment: Other: TABBY; Other: Lingual Frenulum Protocol with Scores for Infants.; Other: Hazelbaker Assessment Tool for Lingual Frenulum Function; Other: Tongue Tie Measurement; Other: Coryllos Scale; Other: Bristol Breastfeeding Assessment Tool; Other: Infant Breastfeeding Assessment Tool; Other: Neonatal Oral-Motor Assessment Scale; Other: LATCH score; Other: Breastfeeding Self Efficacy Scale - Short Form; Other: Nipple pain assessment

Detailed Description

Design: Prospective longitudinal study. The study was approved by the Ethics Committee of Erasme Hospital on May 4, 2022 (Reference : P2022/167/B4062021000404).

Newborns and their mother are recruited at Maternity Ward of Erasme Hospital, HUB Belgium. The dyads are then been followed up to the age of 4 years through clinical examinations, questionnaires and phone calls. Assessments at 6 weeks and 3 months of age are conducted to analyze early outcomes.

Sample size:

Sample size was calculated as follows, based on the calculation of Souza-Oliveira et al.20 : we considered 4.8% incidence of ankyloglossia in newborns based on the study by Messner et al. (2000), a margin of error of 3.0%, and 99.0% of confidence interval. The minimum sample size was 337. From 2022 to 2024, we have already completed our sample recruiting 348 in order to compensate for possible losses in the follow-up.

Primary outcomes: pain during breastfeeding (VAS and Mc Gill Pain Questionary), breastfeeding duration (days), presence of crackled nipples, engorgement, mastitis, nipple bleeding, abscess (breastfeeding complications).

Secondary outcomes:

• frenulum length and width at birth, 1 month, 3 months of life.
• breastfeeding assessment scales: LATCH score, Bristol Breastfeeding Assessment Tool (BBAT), NOMAS (Neonatal Oral-Motor Assessment Scale), Infant Breastfeeding Assessment Tool (IBFAT), Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF).
• Ankyloglossia scales: Hazelbaker Assessment Tool for Lingual Frenulum Function (HATLFF)1, the Tongue-tie and Breastfed Babies (TABBY) scale2, the Lingual Frenulum Protocol with Scores for Infants (LFPI)4, the Coryllos scale3 and the Baxter Infant Examination Form21.
• Muscle tension and joint mobility as manually assessed by an osteopath, and data's from The Myoton Pro (© 2016 Myoton AS), a non-invasive device designed to assess tone, stiffness, elasticity, relaxation time and tissue deformation, on the following muscles: sternocleidomastoid, trapezius, mylohyoid.

AMG-Pediatrics SCIENTIFIC SECTION- 4

Conduction of the Research :

The study has been conducted as follows:

T1 : between 1 and 5 days of the newborn's life, at the postnatal ward, a duo of an osteopath and a pediatrician performed examinations to assess:

A. Newborn's assessment:

1. Neurological status: evaluated using the Amiel-Tison and Gosselin Neurological Assessment from Birth to 6 Years (ENAT) scale, as part of the standard pediatric examination

2. Oral anatomy and function: The baby's frenulum is assessed using multiple standardized scales (HATLFF1, TABBY2, Coryllos3, LFPI4, and Baxter Infant Examination Form).

   A calibrated photographic measurement is taken to assess tongue frenulum's length and width: the tongue was lifted with the examinator's two fingers and a picture of the baby's mouth was taken. A calibration is then used to calculate the length of the frenulum on the picture, using pixelization, by measuring the distance between its origin and insertion. The reliability and reproducibility of these measurements were assessed prior to the study, yielding a Cronbach's alpha of 0.99 and intraclass correlation coefficients (ICC) for interobserver and intraobserver reproducibility of 0.81 and 0.99, respectively.

3. Muscle tension, joint mobility and cranial asymmetry: evaluated via manual osteopathic palpation and Myoton Pro (© 2016 Myoton AS) measurement on specific muscles (sternocleidomastoid, trapezius, mylohyoid).

B. Maternal assessment:

• Medical record review (pregnancy, delivery, breastfeeding-related factors).
• Additional questions related to breastfeeding: previous experience in breastfeeding, duration, reasons for abandoning etc...
• Assessment of maternal well-being: Edinburgh postnatal depression scale (EPDS)21, visual analogue scale for anxiety and fatigue, as those factors are known to influence breastfeeding duration.

During breastfeeding:

• observational scales: BSES-SF, IBFAT, NOMAS, LATCH and BBAT.
• optional videorecording of breastfeeding.
• breastfeeding pain assessment: VAS and McGill Pain Questionnaire.

T2 : At 6 weeks postpartum, after the medical postnatal exam:

• Reassessment of tongue function, oral anatomy, calibrated photography and osteopathic findings (same as T1).
• Breastfeeding evaluation (if continuing) including weight monitoring before/during/after feeding, using OFS-T scale.
• Additional maternal and infant assessments: reflux symptoms (GSQ-I), EPDS, VAS for fatigue/anxiety, Baxter Infant Questionnaire.
• Questions about breastfeeding complications: crackled nipples, engorgement, mastitis, abscess, nipple bleeding.

T3 : At 3 months of age: the same evaluation as T2 are conducted in the parent's home.

T4, T5 and T6: At 6 months, 1 year, and 2 years, structured phone interviews are tracking breastfeeding duration, food diversification problems, feeding behaviors, teething, motor and language development, and sleep patterns.

T7 : At 4 years: in-person assessments include lingual frenulum (Coryllos scale, photographic measurements), dental occlusion (baby-ROMA index), speech and language development (Hénin grid, Evalo 2-6, NEEL phonological/articulation test), and parental questionnaires on language and behavior.

• Study Type: Observational
• Enrollment (Actual): 348

Contacts and Locations

Study Locations

• Belgium
  • Anderlecht
    • Brussels, Anderlecht, Belgium, 1070
      • Hôpital Erasme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy newborns at the maternity ward of Erasme Hospital, Anderlecht, born between 23/05/2022 and 30/09/2024.

Description

Inclusion Criteria:

• Newborn infant with a gestational age ≥ 37 weeks admitted to the postnatal ward of Hospital Erasmus- 1 to 5 days old
• Mother intends to breastfeed at the postnatal ward
• At least one parent has a good understanding of French

Exclusion Criteria:

Newborns will be excluded from the study if they present any of the following:

• Severe medical conditions, including congenital oropharyngeal malformations (e.g. cleft lip, heart defects or brain anomalies) or Prader-Willi syndrome, sepsis, intrauterine growth restriction, need for intensive care
• A positive COVID-19 test (for either the newborn or parents)
• Multiple births (twins, triplets)
• Parents under psychosocial surveillance

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breastfeeding mothers	Other: Bristol Breastfeeding Assessment Tool; Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Bristol Breastfeeding Assessment Tool; Other: Infant Breastfeeding Assessment Tool; Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Infant Breastfeeding Assessment Tool; Other: Neonatal Oral-Motor Assessment Scale; Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Neonatal Oral-Motor Assessment Scale; Other: LATCH score; Assessment of breastfeeding at birth, 6 weeks, 3 months, with the LATCH-Score; Other: Breastfeeding Self Efficacy Scale - Short Form; Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Breastfeeding Self Efficacy Scale - Short Form; Other Names: BSES-SF; Other: Nipple pain assessment; Nipple pain assessment using VAS and the Mc Gill Pain Questionary
Healthy newborns; Newborns will be followed up and assessed for ankyloglossia using TABBY, ATLFF, LFPI and Coryllos scales	Other: TABBY; Assessment of tongue mobility and tongue tie with the TABBY scale at birth, 6 weeks and 3 months of age .; Other: Lingual Frenulum Protocol with Scores for Infants.; Assessment of tongue mobility, function, tongue tie anatomy, nutritive and non nutritive suck using LFPI (Martinelli Scale) at birth, 6 weeks and 3 months of age.; Other Names: Martinelli; Other: Hazelbaker Assessment Tool for Lingual Frenulum Function; Assessment of tongue mobility, function and tongue tie anatomy at birth, 6 weeks and 3 months.; Other Names: HATLFF; Other: Tongue Tie Measurement; A calibrated photographic measurement is taken at birth, 6 weeks and 3 months to assess tongue frenulum's length and width: the tongue was lifted with the examinator's two fingers and a picture of the baby's mouth was taken. A calibration was then used to calculate the length of the frenulum on the picture, using pixelization, by measuring the distance between its origin and insertion; Other: Coryllos Scale; Assessment of the lingual frenulum with the Corollas scale at birth, 6 weeks and 3 months of age; Other: Bristol Breastfeeding Assessment Tool; Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Bristol Breastfeeding Assessment Tool; Other: Infant Breastfeeding Assessment Tool; Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Infant Breastfeeding Assessment Tool; Other: Neonatal Oral-Motor Assessment Scale; Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Neonatal Oral-Motor Assessment Scale; Other: LATCH score; Assessment of breastfeeding at birth, 6 weeks, 3 months, with the LATCH-Score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding duration	Duration of breastfeeding in days	From enrollment to the end of the study at 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue tie length and growth	Tongue tie length at birth, 6 weeks and 3 months, measured by calibrated photographic measurement. A calibration was then used to calculate the length of the frenulum on the picture, using pixelization, by measuring the distance between its origin and insertion.	At birth, 6 weeks of age and 3 months of age
Pain during breastfeeding	pain during breastfeeding at birth, 6 weeks and 3 months, measured by the VAS and Mc Gill Pain Questionary	At birth, 6 weeks of age and 3 months of age
Breastfeeding complications	Presence of crackled nipples, engorgement, mastitis, nipple bleeding, abscess, at birth, 6 weeks and 3 months.	At birth, 6 weeks of age and 3 months of age
Infant Breastfeeding Assessment Tool	Breastfeeding assessed by Infant Breastfeeding Assessment Tool (IBFAT): observational breastfeeding score ranging from 0 to 12 (best score: 12)	At birth, 6 weeks of age and 3 months of age
Breastfeding Self-Efficacy Scale - Short Form	Breastfeeding Self Efficacy ranging from 14 (lower score) to 70 (best score) assessed at birth, at 6 weeks and at 3 months	At birth, 6 weeks of age and 3 months of age
Neonatal Oral Motor Assessment Scale (NOMAS),	Observational scale scoring oral -motor skill as normal, disorganized or dysfunctional (best score: normal)	At birth, 6 weeks of age and 3 months of age
Breastfeeding assessment: LATCH score	LATCH score (observational breastfeeding scale) ranging from 0 to 10 (best score: 10)	At birth, 6 weeks of age and 3 months of age
Bristol Breastfeeding Assessment Tool	Bristol Breastfeeding Assessment Tool (BBAT), observational breatsfeeding scale ranging from 0 to 8 (best score:8).	At birth, 6 weeks of age and 3 months of age
Oro facial praxis- Hénin Grid	At 4 years: in-person assessments will assess speech with :Hénin grid. This grid has standards (acquired - not acquired).	At the age of 4 years
Feeding behaviors	feeding behaviors assessed by structured phone interviews at 6 months, 1 year and 2 years of age.	At the age of 6 months, 1 year and 2 years
dental occlusion	At the age of 4 years dental occlusion will be assessed with the baby-ROMA index.	At the age of 4 years
Orofacial praxies - Evalo 2-6	This grid has standards (acquired - not acquired)	At the age of 4 years
Speech	The NEEL phonological/articulation test will be performed by speech therapists. This test has standards (acquired/ not acquired).	At the age of 4 years

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Collaborators: Université Libre de Bruxelles; King Baudouin Foundation; Fonds Erasme pour la Recherche Médicale
• Investigators: Principal Investigator: Laura J Maroye, PhD Student, Université libre de Bruxelles; Study Director: Jennifer Foucart, PhD, Université libre de Bruxelles; Study Director: Ana Bengoetxea, PhD, Université libre de Bruxelles

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): March 30, 2025
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: tongue tie; ankyloglossia; Prospective study on ankyloglossia; ankyloglossia tools; ankyloglossia scales; ankyloglossia outcomes; ankyloglossia breastfeeding
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Behavior; Feeding Behavior; Ankyloglossia; Breast Feeding
• Other Study ID Numbers: P2022/167/B4062021000404; Fonds Erasme (Other Grant/Funding Number: Fonds Erasme); Fonds Dr. Daniël De Coninck (Other Grant/Funding Number: King Baudouin Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified individual participant data will be shared upon reasonable request.

Requests must include a methodologically sound research proposal and will be reviewed by the study sponsor.

Data will be shared under a data use agreement to ensure participant confidentiality.

• IPD Sharing Time Frame: Beginning 6 months after publication. Available for 5 years.
• IPD Sharing Access Criteria: Individual participant data will be shared with researchers who provide a methodologically sound proposal, for purposes related to achieving the aims outlined in the approved proposal and for secondary research analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No