An observational study in Ankyloglossia, Breastfeeding and Breastfeeding Self-Efficacy, sponsored by Erasme University Hospital. Active, not recruiting at 1 site in Belgium. Open to participants aged 1 Day to 5 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Erasme University Hospital · Observational
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.
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:
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:
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.
B. Maternal assessment:
During breastfeeding:
T2 : At 6 weeks postpartum, after the medical postnatal exam:
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.
32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.
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Healthy newborns at the maternity ward of Erasme Hospital, Anderlecht, born between 23/05/2022 and 30/09/2024.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Newborns will be excluded from the study if they present any of the following:
Newborns will be followed up and assessed for ankyloglossia using TABBY, ATLFF, LFPI and Coryllos scales
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: Bristol Breastfeeding Assessment Tool · Other: Infant Breastfeeding Assessment Tool · Other: Neonatal Oral-Motor Assessment Scale · Other: LATCH score · Other: Nipple pain assessment
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.
Also known as: Martinelli
Assessment of tongue mobility, function and tongue tie anatomy at birth, 6 weeks and 3 months.
Also known as: HATLFF
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
Also known as: BSES-SF
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
Nipple pain assessment using VAS and the Mc Gill Pain Questionary
Breastfeeding duration
Duration of breastfeeding in days
Time frame: From enrollment to the end of the study at 4 years
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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At the age of 4 years
Orofacial praxies - Evalo 2-6
This grid has standards (acquired - not acquired)
Time frame: 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).
Time frame: At the age of 4 years
Plan to share: Yes — 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.
Supporting information: Study protocol
Time frame: Beginning 6 months after publication. Available for 5 years.
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.
Data sharing details ↗ · www.erasme.be
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