Back to resultsEfficacy of Neonatal Release of Ankyloglossia
Primary Purpose
Ankyloglossia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Frentomy
Sham procedure
Sponsored by
About this trial
This is an interventional treatment trial for Ankyloglossia focused on measuring Ankyloglossia, Tongue tie, Frenotomy, Frenulectomy, Breast feeding, HATLFF, IBFAT
Eligibility 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
Sites / Locations
- Naval Medical Center Portsmouth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Frenotomy
No frenotomy
Arm Description
Group of neonates that will receive frenotomy for tongue-tie
Group of infants that will undergo sham procedure (no frenotomy performed)
Outcomes
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
Secondary Outcome Measures
Length of breast feeding
Full Information
NCT ID
NCT00967915
First Posted
August 27, 2009
Last Updated
August 27, 2009
Sponsor
United States Naval Medical Center, Portsmouth
1. Study Identification
Unique Protocol Identification Number
NCT00967915
Brief Title
Efficacy of Neonatal Release of Ankyloglossia
Official Title
Efficacy of Neonatal Release of Ankyloglossia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
United States Naval Medical Center, Portsmouth
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankyloglossia
Keywords
Ankyloglossia, Tongue tie, Frenotomy, Frenulectomy, Breast feeding, HATLFF, IBFAT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Frenotomy
Arm Type
Experimental
Arm Description
Group of neonates that will receive frenotomy for tongue-tie
Arm Title
No frenotomy
Arm Type
Sham Comparator
Arm Description
Group of infants that will undergo sham procedure (no frenotomy performed)
Intervention Type
Procedure
Intervention Name(s)
Frentomy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham procedure
Intervention Description
Infant taken into room away from parents and no frenotomy performed. Infant's mouth is examined but no interventions made.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Length of breast feeding
Time Frame
1 year follow up
10. Eligibility
Sex
All
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21768318
Citation
Buryk M, Bloom D, Shope T. Efficacy of neonatal release of ankyloglossia: a randomized trial. Pediatrics. 2011 Aug;128(2):280-8. doi: 10.1542/peds.2011-0077. Epub 2011 Jul 18.
Results Reference
derived
Learn more about this trial
Efficacy of Neonatal Release of Ankyloglossia
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