Post-Procedural Manual Manipulation for Infant Ankyloglossia

February 11, 2025 updated by: Earl H. Harley, Jr., MD, Georgetown University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Group
In the treatment group, parents will be instructed to perform postprocedural manipulation after the frenotomy.
Other: 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.
Other Names:
  • Post-procedural exercises
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of infants who are recommended to undergo repeat frenotomy
Time Frame: From enrollment to the 2-3 week postoperative visit
Recommendations for frenotomy revision will be made by the principal investigator during the post-operative visit, which occurs 2-3 weeks following the procedure. This will include a physical examination to assess post-operative healing, along with an evaluation of the mother's breastfeeding outcomes.
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
Pre- and post-operative maternal breastfeeding performance will be assessed using the LATCH score, a validated questionnaire that evaluates breastfeeding effectiveness. The pre-operative score will be administered during the initial consultation, while the post-operative score will be taken at the follow-up visit, 2-3 weeks after the procedure. The difference in scores will be analyzed to determine if there is an improvement in maternal breastfeeding outcomes.
From enrollment to the 2-3 week postoperative visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance with post-frenotomy stretching and exercises
Time Frame: From enrollment to the 1 week postoperative phone call
Parents assigned to the treatment group will receive a phone call one week postoperatively to assess their adherence to the treatment plan.
From enrollment to the 1 week postoperative phone call

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Investigators

  • Principal Investigator: Earl H Harley, MD, MedStar Georgetown University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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