Condition: Ankyloglossia · Breastfeeding Support · Sponsor: Georgetown University
The goal of this randomized control trial is to determine the impact of post-frenotomy manual manipulation on revision rates and breastfeeding outcomes. We hypothesize that post-frenotomy manipulation will reduce the rate of sublingual frenulum regrowth, and subsequently frenotomy revision rates, thereby improving breastfeeding performance. Infants with ankyloglossia undergoing frenotomy will be randomized into two groups: the intervention group (post-frenotomy manipulation) and the control group (no intervention). Parents in the intervention group will be instructed to perform tongue stretching and suck "re-training" exercises four times daily for 2-3 weeks, beginning 24 hours post-procedure. To monitor adherence and assess any complications, investigators will conduct a follow-up phone call one week after the procedure. Parents in the control group will not be instructed to perform any post-procedural manipulation. All participants will have a mandatory in-person follow-up 2-3 weeks postoperatively, during which breastfeeding outcomes and the need for frenotomy revision will be evaluated.
This description comes directly from the study's public registry record.
Emily A Clementi, BA · (202) 444-8186 · eac166@georgetown.edu
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| MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery | Washington D.C., District of Columbia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06830148