RECRUITING

Post-Procedural Manual Manipulation for Infant Ankyloglossia

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Conditions

AnkyloglossiaBreastfeeding Supporttongue tiebreastfeedingexercisesinfantpediatric otolaryngologyfrenotomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-15
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06830148

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.

Ages Eligible for Study:Not specified to 90 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * infants less than 90 days old with ankyloglossia who undergo outpatient frenotomy using cold-steel scissors and will be exclusively or partially breastfed.
  1. * 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.
  2. * 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

Contacts and Locations

Study Contact

Emily A Clementi, BA
CONTACT
(202) 444-8186
eac166@georgetown.edu

Principal Investigator

Earl H Harley, MD
PRINCIPAL_INVESTIGATOR
MedStar Georgetown University Hospital

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Georgetown University

  • Earl H Harley, MD, PRINCIPAL_INVESTIGATOR, MedStar Georgetown University Hospital

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 Registration Dates

Study Start Date2024-10-15
Study Completion Date2025-11

Study Record Updates

Study Start Date2024-10-15
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Ankyloglossia
  • Breastfeeding Support