Efficacy of Neonatal Release of Ankyloglossia
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.
|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|
- 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 ]
- Length of breast feeding [ Time Frame: 1 year follow up ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Group of neonates that will receive frenotomy for tongue-tie
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967915
|United States, Virginia|
|Naval Medical Center Portsmouth|
|Portsmouth, Virginia, United States, 23708|