Efficacy of Neonatal Release of Ankyloglossia
- Conditions
- Ankyloglossia
- Registration Number
- NCT00967915
- Lead Sponsor
- United States Naval Medical Center, Portsmouth
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- Significant ankyloglossia as judged by Hazelbaker scale (HATLFF)
- Report of maternal nipple pain with feeding
- Report of difficulty with infant breast feeding
- Significant craniofacial defects
- Age >14 days at enrollment
- Any maternal contraindication to breastfeeding
- Neurologic defects that would impair breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Length of breast feeding 1 year follow up
Trial Locations
- Locations (1)
Naval Medical Center Portsmouth
🇺🇸Portsmouth, Virginia, United States
Naval Medical Center Portsmouth🇺🇸Portsmouth, Virginia, United States