NCT07512765

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 348 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 5 Days
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Ankyloglossia
• Breastfeeding
• Breastfeeding Self-Efficacy
• Breastfeeding Duration
• Breastfeeding Outcomes

Interventions

Type	Name	Description
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	Hazelbaker Assessment Tool for Lingual Frenulum Function	Assessment of tongue mobility, function and tongue tie anatomy at birth, 6 weeks and 3 months.
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	Breastfeeding Self Efficacy Scale - Short Form	Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Breastfeeding Self Efficacy Scale - Short Form
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	Nipple pain assessment	Nipple pain assessment using VAS and the Mc Gill Pain Questionary

Timeline

• Start date: 2022-05-23
• Primary completion: 2025-03-30
• Completion: 2028-12-31
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: Belgium