An interventional study of Post-frenotomy manual manipulation in Ankyloglossia and Breastfeeding Support, sponsored by Georgetown University. Recruiting at 1 site in United States. Open to participants aged Up to 90 Days. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Georgetown University · Not applicable, Interventional, and Supportive care
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.
32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.
This study's planned enrollment of 110 is close to the median of 105 across 22 interventional studies indexed under Ankyloglossia.
Browse Ankyloglossia studies →Georgetown University is the lead sponsor of 292 studies on the registry; 40 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
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Exclusion Criteria:
In the treatment group, parents will be instructed to perform postprocedural manipulation after the frenotomy.
Other: Post-frenotomy manual manipulation
In the control group, parents will not receive any instructions to perform "suck re-training" exercises or stretching following the procedure.
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
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.
Time frame: 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.
Time frame: From enrollment to the 2-3 week postoperative visit
Compliance with post-frenotomy stretching and exercises
Parents assigned to the treatment group will receive a phone call one week postoperatively to assess their adherence to the treatment plan.
Time frame: From enrollment to the 1 week postoperative phone call
Plan to share: No
Started Oct 2024 (actual). Primary completion is estimated for Oct 2025, 12 months after the start.
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