Actively Recruiting

Phase Not Applicable
Age: 0 - 90Days
All Genders
ID06830148

Effectiveness of Post-Procedural Manual Manipulation for Infant Ankyloglossia in Enhancing Breastfeeding and Reducing Revision Rates: A Prospective Randomized Trial

Led by Georgetown University · Updated on 2025-02-17

110

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial studies infants with ankyloglossia, commonly known as tongue-tie, to see if doing manual tongue exercises after a frenotomy (a procedure to release the tongue) can reduce the need for repeat procedures and improve breastfeeding. The research aims to compare outcomes between babies who do these exercises after surgery and those who do not. The study is a randomized controlled trial led by Georgetown University, focusing on how manual manipulation may affect tongue healing and feeding success. Infants under 90 days old who have a frenotomy with cold-steel scissors and are at least partly breastfed are randomly assigned to one of two groups. In the treatment group, parents will perform tongue stretching and suck re-training exercises four times a day for 2 to 3 weeks, starting 24 hours after the procedure. The control group will not receive instructions for any exercises. Follow-ups include a phone call one week after surgery and an in-person visit 2 to 3 weeks after to review breastfeeding and any need for further frenotomy. During the study, researchers will track how well parents follow the exercise plan and monitor any problems through the phone follow-up. At the in-person visit, they will evaluate breastfeeding performance and determine if another frenotomy is needed. The main outcomes measured are the rate of repeat frenotomies and improvements in breastfeeding from the time of enrollment to the postoperative visit. Participation lasts about 2 to 3 weeks after the procedure.

CONDITIONS

Brief Title

Post-Procedural Manual Manipulation for Infant Ankyloglossia

Who Can Participate

Age: 0 - 90Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants less than 90 days old with ankyloglossia
  • Undergoing outpatient frenotomy using cold-steel scissors
  • Exclusively or partially breastfed
Not Eligible

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 undergone a frenotomy
  • Infants with gestational age less than 36 weeks
  • Infants in the NICU or post-partum unit
  • Infants who did not receive the vitamin K injection
  • Infants with congenital anomalies or medical conditions affecting breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 2 to 3 weeks

Participants who undergo frenotomy will either perform or not perform post-procedural manual manipulation exercises as instructed.

1 postoperative visit and 1 follow-up phone call

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

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Research Team

E

Emily A Clementi, BA

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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Published Research Related To This Trial