Post-Procedural Manual Manipulation for Infant Ankyloglossia

NCT06830148 | Recruiting

• 1 other identifier: STUDY00008313
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankyloglossia; Breastfeeding Support

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Proportion of infants who are recommended to undergo repeat frenotomy

  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

  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 Outcomes (1)

• Compliance with post-frenotomy stretching and exercises

  From enrollment to the 1 week postoperative phone call

Study Arms (2)

Exercise Group

EXPERIMENTAL

In the treatment group, parents will be instructed to perform postprocedural manipulation after the frenotomy.

Other: Post-frenotomy manual manipulation

Control Group

NO INTERVENTION

In the control group, parents will not receive any instructions to perform "suck re-training" exercises or stretching following the procedure.

Interventions

Post-frenotomy manual manipulation OTHER

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.

Also known as: Post-procedural exercises

Exercise Group

Eligibility Criteria

• Age: Up to 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 33852342 BACKGROUND

• 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.

  PMID: 32283998 BACKGROUND

MeSH Terms

Conditions

Ankyloglossia; Breast Feeding; Motor Activity

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Feeding Behavior; Behavior

Study Officials

• Earl H Harley, MD

  MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily A Clementi, BA

CONTACT

(202) 444-8186; eac166@georgetown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Pediatric Otolaryngology and Professor of Otolaryngology and Pediatrics

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: October 15, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)