Clinical trial NCT06830148: Post-Procedural Manual Manipulation for Infant Ankyloglossia
Official title: Effectiveness of Post-Procedural Manual Manipulation for Infant Ankyloglossia in Enhancing Breastfeeding and Reducing Revision Rates: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankyloglossia
Breastfeeding Support
Keywords: tongue tie
breastfeeding
exercises
infant
pediatric otolaryngology
frenotomy
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 110
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: 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

Primary outcomes:
measure: Proportion of infants who are recommended to undergo repeat frenotomy
timeFrame: From enrollment to the 2-3 week postoperative visit
measure: Improvement in breastfeeding performance following post-procedural manual manipulation
timeFrame: From enrollment to the 2-3 week postoperative visit
Secondary outcomes:
measure: Compliance with post-frenotomy stretching and exercises
timeFrame: From enrollment to the 1 week postoperative phone call
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery
state: District of Columbia
Study officials:
affiliation: MedStar Georgetown University Hospital
name: Earl H Harley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: LeFort Y, Evans A, Livingstone V, Douglas P, Dahlquist N, Donnelly B, Leeper K, Harley E, Lappin S. Academy of Breastfeeding Medicine Position Statement on Ankyloglossia in Breastfeeding Dyads. Breastfeed Med. 2021 Apr;16(4):278-281. doi: 10.1089/bfm.2021.29179.ylf. No abstract available.
citation: Messner AH, Walsh J, Rosenfeld RM, Schwartz SR, Ishman SL, Baldassari C, Brietzke SE, Darrow DH, Goldstein N, Levi J, Meyer AK, Parikh S, Simons JP, Wohl DL, Lambie E, Satterfield L. Clinical Consensus Statement: Ankyloglossia in Children. Otolaryngol Head Neck Surg. 2020 May;162(5):597-611. doi: 10.1177/0194599820915457. Epub 2020 Apr 14.