NCT00967915

Efficacy of Neonatal Release of Ankyloglossia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: United States Naval Medical Center, Portsmouth · Federal
• Sex: All
• Age: 0 Days – 14 Days
• Healthy volunteers: Accepted

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.

Conditions

• Ankyloglossia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-08-28
• Last updated: 2024-05-10

Locations

1 site across 1 country: United States