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Post-Procedural Manual Manipulation for Infant Ankyloglossia

RecruitingNAAges any - 90 DaysAllGeorgetown University
NCT06830148 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 an

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📋 Eligibility rules (as published)
Inclusion Criteria: * infants less than 90 days old with ankyloglossia who undergo outpatient frenotomy using cold-steel scissors and will be exclusively or partially breastfed. Exclusion Criteria: * infants older than 90 days, those who will be exclusively bottle fed, infants who undergo concomitant lip tie release, those who undergo laser frenotomy, and infants who have previously undergone a frenotomy. * infants with a gestational age of less than 36 weeks, those in the NICU or post-partum unit, infants who didn't receive the vitamin K injection, and those with congenital anomalies or medical conditions affecting breastfeeding
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What it tests

  • Post-frenotomy manual manipulation
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Where

1 site
MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery
Washington D.C., United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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