Efficacy of Neonatal Release of Ankyloglossia

Ankyloglossia Clinical Trial

Official title:

Efficacy of Neonatal Release of Ankyloglossia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967915
• Other study ID #: 2007.0077
• Status: Completed
• Phase: N/A
• First received: August 27, 2009
• Last updated: August 27, 2009
• Start date: November 2007

Study information

• Verified date: August 2009
• Source: United States Naval Medical Center, Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankyloglossia
• Mouth Abnormalities

Intervention

Procedure:
• Frentomy
Frenotomy will be performed. This procedure involves crushing frenulum tissue with straight hemostat for hemostasis and anesthesia while tongue is elevated with elevator. Frenulum then cut to desired length with iris scissors. Patient then returned to parents and immediately breastfeeds without parent observing infant's mouth.

Other:
• Sham procedure
Infant taken into room away from parents and no frenotomy performed. Infant's mouth is examined but no interventions made.

Locations

Country	Name	City	State
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, Portsmouth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Length of breast feeding		1 year follow up	No