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NCT Number: NCT06830148

Post-Procedural Manual Manipulation for Infant Ankyloglossia

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.

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Key information

Conditions

Ankyloglossia Behavior Breast Feeding Breastfeeding Support Feeding Behavior Motor Activity Stomatognathic Diseases

Age range

Up to 90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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

Location status: Recruiting

Location contact

Emily A Clementi, BA

CONTACT

[email protected]

(202) 444-8186

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Post-procedural exercises

Primary outcomes

  1. Proportion of infants who are recommended to undergo repeat frenotomy

    Time frame: From enrollment to the 2-3 week postoperative visit

    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.

  2. Improvement in breastfeeding performance following post-procedural manual manipulation

    Time frame: From enrollment to the 2-3 week postoperative visit

    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.

Secondary outcomes

  1. Compliance with post-frenotomy stretching and exercises

    Time frame: From enrollment to the 1 week postoperative phone call

    Parents assigned to the treatment group will receive a phone call one week postoperatively to assess their adherence to the treatment plan.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily A Clementi, BA

CONTACT

[email protected]

(202) 444-8186

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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