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ANK-PROS
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Fonds Erasme
OTHER_GRANT · King Baudouin Foundation
observational
348
1 country
1
Study Start
May 23, 2022
Actual (reported)Primary Completion
March 30, 2025
Actual (reported)Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 23, 2022
Actual (reported)March 30, 2025
Actual (reported)December 30, 2025
Actual (reported)April 6, 2026
Actual (reported)December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Breastfeeding duration
Duration of breastfeeding in days
From enrollment to the end of the study at 4 years
Tongue tie length and growth
At birth, 6 weeks of age and 3 months of age
Pain during breastfeeding
At birth, 6 weeks of age and 3 months of age
Breastfeeding complications
Newborns will be followed up and assessed for ankyloglossia using TABBY, ATLFF, LFPI and Coryllos scales
Assessment of tongue mobility and tongue tie with the TABBY scale at birth, 6 weeks and 3 months of age .
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.
Healthy newborns at the maternity ward of Erasme Hospital, Anderlecht, born between 23/05/2022 and 30/09/2024.
Hopital Erasme
Brussels, Anderlecht, 1070, Belgium
Laura J Maroye, PhD Student
Université Libre de Bruxelles
Jennifer Foucart, PhD
Université Libre de Bruxelles
Ana Bengoetxea, PhD
Université Libre de Bruxelles
348 participants (actual enrollment reported by the registry).
First Submitted
December 30, 2025
First Posted
April 6, 2026
Study Start
May 23, 2022
Actual (reported)At birth, 6 weeks of age and 3 months of age
Infant Breastfeeding Assessment Tool
At birth, 6 weeks of age and 3 months of age
Breastfeding Self-Efficacy Scale - Short Form
At birth, 6 weeks of age and 3 months of age
Nipple pain assessment using VAS and the Mc Gill Pain Questionary
Assessment of tongue mobility, function and tongue tie anatomy at birth, 6 weeks and 3 months.
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
Assessment of the lingual frenulum with the Corollas scale at birth, 6 weeks and 3 months of age
Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Breastfeeding Self Efficacy Scale - Short Form
Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Bristol Breastfeeding Assessment Tool
Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Infant Breastfeeding Assessment Tool
Assessment of breastfeeding at birth, 6 weeks, 3 months, with the Neonatal Oral-Motor Assessment Scale
Assessment of breastfeeding at birth, 6 weeks, 3 months, with the LATCH-Score
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
March 30, 2025
Actual (reported)Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 6, 2026
Record last verified: 2025-12
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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