An interventional study of Frentomy and Sham procedure in Ankyloglossia, sponsored by United States Naval Medical Center, Portsmouth. Completed at 1 site in United States. Open to participants aged 0 Days to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by United States Naval Medical Center, Portsmouth · Not applicable, Interventional, and Treatment
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.
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.
29 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.
This study's enrollment of 58 is below the median of 110 across 21 interventional studies indexed under Ankyloglossia.
Browse Ankyloglossia studies →United States Naval Medical Center, Portsmouth is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Group of neonates that will receive frenotomy for tongue-tie
Procedure: Frentomy
Group of infants that will undergo sham procedure (no frenotomy performed)
Other: Sham procedure
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.
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
Length of breast feeding
Time frame: 1 year follow up
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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United States Naval Medical Center, Portsmouth