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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3 months
Healthy Volunteers: f
View:

• infants less than 90 days old with ankyloglossia who undergo outpatient frenotomy using cold-steel scissors and will be exclusively or partially breastfed.

Locations
United States
Washington, D.c.
MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery
RECRUITING
Washington D.c.
Contact Information
Primary
Emily A Clementi, BA
eac166@georgetown.edu
(202) 444-8186
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2025-11
Participants
Target number of participants: 110
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Georgetown University

This content was sourced from clinicaltrials.gov

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