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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00967915
Other study ID # 2007.0077
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2007
Est. completion date July 2009

Study information

Verified date May 2024
Source United States Naval Medical Center, Portsmouth
Contact n/a
Is FDA regulated No
Health authority
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. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Days 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


Related Conditions & MeSH terms


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
Secondary Length of breast feeding 1 year follow up
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