Efficacy of Neonatal Release of Ankyloglossia

This study has been completed.
Sponsor:
Information provided by:
United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT00967915
First received: August 27, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Ankyloglossia
Procedure: Frentomy
Other: Sham procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Efficacy of Neonatal Release of Ankyloglossia

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, Portsmouth:

Primary Outcome Measures:
  • Maternal nipple pain as judged by R. Melzack's short form pain scale and infant breast feeding as judged by IBFAT scale [ Time Frame: immediately following 1st breast feed, and at 2 week, 2,4,6 12 month follow ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of breast feeding [ Time Frame: 1 year follow up ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: November 2007
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Frenotomy
Group of neonates that will receive frenotomy for tongue-tie
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.
Sham Comparator: No frenotomy
Group of infants that will undergo sham procedure (no frenotomy performed)
Other: Sham procedure
Infant taken into room away from parents and no frenotomy performed. Infant's mouth is examined but no interventions made.

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.

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967915

Locations
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
  More Information

No publications provided by United States Naval Medical Center, Portsmouth

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00967915     History of Changes
Other Study ID Numbers: 2007.0077
Study First Received: August 27, 2009
Last Updated: August 27, 2009
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by United States Naval Medical Center, Portsmouth:
Ankyloglossia
Tongue tie
Frenotomy
Frenulectomy
Breast feeding
HATLFF
IBFAT

Additional relevant MeSH terms:
Mouth Abnormalities
Mouth Diseases
Stomatognathic Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 21, 2014