Tongue tie and frenotomy: a feasibility randomised controlled trial

Completed

• Conditions: Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics; Not Applicable; Ankyloglossia

• Registration Number: ISRCTN73554751
• Lead Sponsor: Southmead Hospital (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Term born infants with a functionally significant tongue tie (Hazelbaker Assessment Tool for Lingual Frenulum Function [HATLFF] score between 6-12) with breast feeding difficulties (LATCH score <-8)
2. Male and female participants
3. Upper Age Limit is 14 days

Exclusion Criteria

1. Preterm infants
2. Infants with serious congenital anomalies
3. Infants who have lost >10% of their birth weight unless found to be well enough after checking by a neonatologist
4. Infants with a HATLFF score of <6, and those over 2 weeks old will be excluded from the study
5. Mothers who do not want their baby to have surgery
6. Babies that have not received vitamin K soon after birth, unless the mother agrees to an injection of vitamin K one hour before entering the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ATCH score, measured pre and post frenotomy

Secondary Outcome Measures

Name	Time	Method
1. Bresat feeding duration measured 8 weeks post procedure<br>2. HASLIFF score measured pre and post frenotomy<br>3. Maternal pain on breast feeding Likert scale measured pre and post frenotomy