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RECRUITING
NCT06830148
NA

Post-Procedural Manual Manipulation for Infant Ankyloglossia

Sponsor: Georgetown University

View on ClinicalTrials.gov

Summary

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.

Official title: Effectiveness of Post-Procedural Manual Manipulation for Infant Ankyloglossia in Enhancing Breastfeeding and Reducing Revision Rates: A Prospective Randomized Trial

Key Details

Gender

All

Age Range

Any - 90 Days

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2024-10-15

Completion Date

2025-11

Last Updated

2025-02-17

Healthy Volunteers

No

Interventions

OTHER

Post-frenotomy manual manipulation

Parents assigned to the treatment group will be instructed to perform post-frenotomy stretches and exercises four times daily, after every other feed, until the time of their postoperative visit 2-3 weeks later.

Locations (1)

MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery

Washington D.C., District of Columbia, United States