Post-Procedural Manual Manipulation for Infant Ankyloglossia

Georgetown University

Status: Enrolling

Conditions: Ankyloglossia; Breastfeeding Support

Treatments: Other: Post-frenotomy manual manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06830148

STUDY00008313

Details and patient eligibility

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.

Enrollment: 110 estimated patients

Sex: All

Ages: Under 90 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Exercise Group

Experimental group

Description:

In the treatment group, parents will be instructed to perform postprocedural manipulation after the frenotomy.

Treatment:

Other: Post-frenotomy manual manipulation

Control Group

No Intervention group

Description:

In the control group, parents will not receive any instructions to perform "suck re-training" exercises or stretching following the procedure.