Clinical Research Directory
Browse clinical research sites, groups, and studies.
Ankyloglossia and Its Effects on Breastfeeding, Feeding and Speech Disorders. A Prospective Study From Birth to 4 Years of Age.
Sponsor: Erasme University Hospital
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.
Key Details
Gender
All
Age Range
1 Day - 5 Days
Study Type
OBSERVATIONAL
Enrollment
348
Start Date
2022-05-23
Completion Date
2028-12-31
Last Updated
2026-04-06
Healthy Volunteers
Yes
Conditions
Interventions
TABBY
Assessment of tongue mobility and tongue tie with the TABBY scale at birth, 6 weeks and 3 months of age .
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.
Hazelbaker Assessment Tool for Lingual Frenulum Function
Assessment of tongue mobility, function and tongue tie anatomy at birth, 6 weeks and 3 months.
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
Coryllos Scale
Assessment of the lingual frenulum with the Corollas scale at birth, 6 weeks and 3 months of age
Breastfeeding Self Efficacy Scale - Short Form
Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Breastfeeding Self Efficacy Scale - Short Form
Bristol Breastfeeding Assessment Tool
Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Bristol Breastfeeding Assessment Tool
Infant Breastfeeding Assessment Tool
Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Infant Breastfeeding Assessment Tool
Neonatal Oral-Motor Assessment Scale
Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Neonatal Oral-Motor Assessment Scale
LATCH score
Assessment of breastfeeding at birth, 6 weeks, 3 months, with the LATCH-Score
Nipple pain assessment
Nipple pain assessment using VAS and the Mc Gill Pain Questionary
Locations (1)
Hopital Erasme
Brussels, Anderlecht, Belgium