Efficacy of Neonatal Release of Ankyloglossia

Not Applicable

Completed

• Conditions: Ankyloglossia
• Interventions: Procedure: Frentomy; Other: Sham procedure

• Registration Number: NCT00967915
• Lead Sponsor: United States Naval Medical Center, Portsmouth

Brief Summary

The purpose of this study is to determine if frenotomy for ankyloglossia will improve infant breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the hypothesis that frenotomy will do all of the above.

Detailed Description

The primary objective of our study is to determine if frenotomy (or release of tongue tie) for ankyloglossia (tongue tie) will decrease maternal nipple pain with breast feeding and improve infant's ability to breast feed. Our secondary objective is to determine if frenotomy for ankyloglossia will improve the length of time a mother breast feeds. Our hypothesis is that frenotomy will decrease maternal nipple pain, improve infant's breast feeding and prolong the duration of breast feeding.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-27
• Study First Posted: 2009-08-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Significant ankyloglossia as judged by Hazelbaker scale (HATLFF)
• Report of maternal nipple pain with feeding
• Report of difficulty with infant breast feeding

Exclusion Criteria

• Significant craniofacial defects
• Age >14 days at enrollment
• Any maternal contraindication to breastfeeding
• Neurologic defects that would impair breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Frenotomy	Frentomy	Group of neonates that will receive frenotomy for tongue-tie
No frenotomy	Sham procedure	Group of infants that will undergo sham procedure (no frenotomy performed)

Primary Outcome Measures

Name	Time	Method
Maternal nipple pain as judged by R. Melzack's short form pain scale and infant breast feeding as judged by IBFAT scale	immediately following 1st breast feed, and at 2 week, 2,4,6 12 month follow ups

Secondary Outcome Measures

Name	Time	Method
Length of breast feeding	1 year follow up

Trial Locations

Locations (1)

Naval Medical Center Portsmouth; 🇺🇸 Portsmouth, Virginia, United States