Efficacy of Neonatal Release of Ankyloglossia
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 27, 2009
CompletedFirst Posted
Study publicly available on registry
August 28, 2009
CompletedMay 10, 2024
May 1, 2024
1.7 years
August 27, 2009
May 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Length of breast feeding
1 year follow up
Study Arms (2)
Frenotomy
EXPERIMENTALGroup of neonates that will receive frenotomy for tongue-tie
No frenotomy
SHAM COMPARATORGroup of infants that will undergo sham procedure (no frenotomy performed)
Interventions
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.
Infant taken into room away from parents and no frenotomy performed. Infant's mouth is examined but no interventions made.
Eligibility Criteria
You may qualify if:
- Significant ankyloglossia as judged by Hazelbaker scale (HATLFF)
- Report of maternal nipple pain with feeding
- Report of difficulty with infant breast feeding
You may not qualify if:
- Significant craniofacial defects
- Age \>14 days at enrollment
- Any maternal contraindication to breastfeeding
- Neurologic defects that would impair breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708, United States
Related Publications (1)
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.
PMID: 21768318DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2009
First Posted
August 28, 2009
Study Start
November 1, 2007
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
May 10, 2024
Record last verified: 2024-05