Recruiting

Manual Manipulation

Sponsor:

Georgetown University

Code:

NCT06830148

Conditions

Ankyloglossia

Breastfeeding Support

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Post-frenotomy manual manipulation

Study Details

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.

Conditions

Ankyloglossia

Breastfeeding Support

Study ID

NCT06830148

Start date

Oct 15, 2024

Status verified date

Nov, 2024

Completion date

Nov, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Proportion of infants who are recommended to undergo repeat frenotomy [ Time Frame: From enrollment to the 2-3 week postoperative visit ]
  • Improvement in breastfeeding performance following post-procedural manual manipulation [ Time Frame: From enrollment to the 2-3 week postoperative visit ]

Central Contacts and Locations

Central contacts

Emily A Clementi, BA

(202) 444-8186eac166@georgetown.edu

Locations

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

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Emily A Clementi, BA

(202) 444-8186eac166@georgetown.edu

More Information

Sponsor

Georgetown University

Last update posted

Feb 17, 2025

Last verified

Nov, 2024

Keywords

  • tongue tie
  • breastfeeding
  • exercises
  • infant
  • pediatric otolaryngology
  • frenotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2025-02-17.