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Purpose

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

Eligibility

Eligible Ages
Under 90 Days
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery
Washington, District of Columbia 20007
Contact:
Emily A Clementi, BA
(202) 444-8186
eac166@georgetown.edu

More Details

Status
Recruiting
Sponsor
Georgetown University

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.