NCT06830148 Post-Procedural Manual Manipulation for Infant Ankyloglossia
| NCT ID | NCT06830148 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Georgetown University |
| Condition | Ankyloglossia |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-10-15 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-10-15 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Earl H Harley, MD
PRINCIPAL INVESTIGATOR
MedStar Georgetown University Hospital
Frequently Asked Questions
Who can join the NCT06830148 clinical trial?
This trial is open to participants of all sexes, up to 90 Days, studying Ankyloglossia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06830148 currently recruiting?
Yes, NCT06830148 is actively recruiting participants. Contact the research team at eac166@georgetown.edu for enrollment information.
Where is the NCT06830148 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT06830148 clinical trial?
NCT06830148 is sponsored by Georgetown University. The principal investigator is Earl H Harley, MD at MedStar Georgetown University Hospital. The trial plans to enroll 110 participants.