Breastfeeding Duration and Tongue-tie in Neonates.

NCT05946590 | Completed DMC

• 1 other identifier: VEC 99694
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to examine how performed frenotomy in term-born infants influences the breastfeeding duration. The main questions the study aims to answer are how a suspected tongue-tie, vacuum strength, and breastfeeding may be associated. Families of infants with tongue-tie where frenotomy is suspected will be invited to participate. Intra-oral vacuum measurements before and 5-10 days after frenotomy will be obtained and the breastfeeding status followed for 6 months.

Conditions

Infant Nutrition Disorders

Keywords

Ankyloglossia; Frenotomy; Infants; Intra-oral vacuum; Breastfeeding

Outcome Measures

Primary Outcomes (1)

• Breastfeeding duration

  The duration of exclusive and partial breastfeeding

  Followed 6 months.

Secondary Outcomes (2)

• TABBY score

  Before and 5-10 days after performed frenotomy.

• Delta intra-oral vacuum

  Before, within 1 hour after and 5-10 days after performed frenotomy.

Study Arms (1)

Frenotomy

OTHER

Frenotomy performed by a health care professional

Procedure: Frenotomy

Interventions

Frenotomy PROCEDURE

Frenotomy in which clipping/incised of the lingual frenulum releases the tongue-tie performed by a health care professional

Also known as: Frenulum release

Frenotomy

Eligibility Criteria

• Age: Up to 49 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infant of an adult mother Delivery after 37 completed gestational weeks. Singleton or twin Infant of a mother who intends to breastfeed. At least one parents speak and write English, Danish, Norwegian, or Swedish.

You may not qualify if:

• Congenital malformation. Reduced lung function.

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Diana Skaaning

Hvidovre, Copenhagen, 2650, Denmark

Location

MeSH Terms

Conditions

Infant Nutrition Disorders; Ankyloglossia; Breast Feeding

Interventions

Oral Frenectomy

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Stomatognathic Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Officials

• Diana Skaaning

  Region Hovedstadens Apotek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Supervisor

Model Details: An exploratory prospective cohort study.

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 14, 2023
• Study Start: November 17, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 19, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)