Actively Recruiting
Post-Procedural Manual Manipulation for Infant Ankyloglossia
Led by Georgetown University · Updated on 2025-02-17
110
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-Procedural Manual Manipulation for Infant Ankyloglossia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants less than 90 days old with ankyloglossia
- Undergoing outpatient frenotomy using cold-steel scissors
- Exclusively or partially breastfed
You will not qualify if you...
- Infants older than 90 days
- Exclusively bottle fed infants
- Infants undergoing concomitant lip tie release
- Infants undergoing laser frenotomy
- Infants who have previously had a frenotomy
- Infants born before 36 weeks gestation
- Infants currently in the NICU or post-partum unit
- Infants who did not receive vitamin K injection
- Infants with congenital anomalies or medical conditions that affect breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
Research Team
E
Emily A Clementi, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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