Post-Procedural Manual Manipulation for Infant Ankyloglossia

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT06830148
Status
Recruiting
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Conditions

  • Ankyloglossia
  • Breastfeeding Support

Eligibility Criteria

Sex
ALL
Age
N/A - 90 Days
Healthy Volunteers
Not accepted

Interventions

  • Post-frenotomy manual manipulation — OTHER
    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.

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
Nov 2024
Primary completion
Oct 31, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Exercise Group
    In the treatment group, parents will be instructed to perform postprocedural manipulation after the frenotomy.
  • No Intervention: Control Group
    In the control group, parents will not receive any instructions to perform "suck re-training" exercises or stretching following the procedure.

Primary Outcome Measure

Proportion of infants who are recommended to undergo repeat frenotomy [ Time Frame: From enrollment to the 2-3 week postoperative visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck SurgeryWashington D.C.District of Columbia20007
Emily A Clementi, BA
[email protected]
(202) 444-8186

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By research site
MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery· Washington D.C., DC

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