NCT07512765 (ANK-PROS) is a clinical trial of TABBY in Ankyloglossia, sponsored by Erasme University Hospital.

Who is sponsoring NCT07512765?

NCT07512765 is sponsored by Erasme University Hospital.

What drugs are being tested in NCT07512765?

Interventions in NCT07512765: TABBY, Lingual Frenulum Protocol with Scores for Infants., Hazelbaker Assessment Tool for Lingual Frenulum Function, Tongue Tie Measurement, Coryllos Scale, Breastfeeding Self Efficacy Scale - Short Form, Bristol Breastfeeding Assessment Tool, Infant Breastfeeding Assessment Tool, Neonatal Oral-Motor Assessment Scale, LATCH score, Nipple pain assessment.

What condition does NCT07512765 study?

NCT07512765 studies Ankyloglossia, Breastfeeding, Breastfeeding Self-Efficacy, Breastfeeding Duration, Breastfeeding Outcomes.

Is NCT07512765 still recruiting?

NCT07512765 is currently active, enrolled. Last updated 6 April 2026.

Last reviewed 2026-04-06 · How we verify

NCT07512765: ANK-PROS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Last updated 6 April 2026

What this trial tests

trial testing TABBY in Ankyloglossia in 348 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

23 May 2022

Primary endpoint
30 March 2025

31 December 2028

Quick facts

Lead sponsor	Erasme University Hospital
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	348
Start date	23 May 2022
Primary completion	30 March 2025
Estimated completion	31 December 2028
Sites	1 location across Belgium

Drugs / interventions tested

TABBY
Lingual Frenulum Protocol with Scores for Infants.
Hazelbaker Assessment Tool for Lingual Frenulum Function
Tongue Tie Measurement
Coryllos Scale
Breastfeeding Self Efficacy Scale - Short Form
Bristol Breastfeeding Assessment Tool
Infant Breastfeeding Assessment Tool
Neonatal Oral-Motor Assessment Scale
LATCH score
Nipple pain assessment

Conditions studied

Ankyloglossia — all drugs for Ankyloglossia →
Breastfeeding — all drugs for Breastfeeding →
Breastfeeding Self-Efficacy — all drugs for Breastfeeding Self-Efficacy →
Breastfeeding Duration — all drugs for Breastfeeding Duration →

Sponsor

Erasme University Hospital

Who can join

Adults 1 Day to 5 Days, any sex, with Ankyloglossia or Breastfeeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other Erasme University Hospital trials

Trials by the same sponsor.

NCT07532733 — Respiratory and Haemodynamic Effects of Conscious Sedation With Dexmedetomidine for a TAVI Procedure · NA · not yet recruiting
NCT07532681 — Effect of Early Versus Late Surgical Intercostal Block on Postoperative Pain Relief Following Video-Assisted Thoracic Su · NA · not yet recruiting
NCT07457879 — Impact of the Reimbursement of Fibrinogen in Cardiac Surgery · not yet recruiting
NCT07184593 — Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients · not yet recruiting
NCT07369232 — Cerebral Hemodynamic Effects of Oxygen and Antioxidants (CHEOXANT) · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07512765 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Erasme University Hospital
Last refreshed: 6 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07512765.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing