Post-Procedural Manual Manipulation for Infant Ankyloglossia
NCT ID: NCT06830148
Last Updated: 2025-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2024-10-15
2025-11-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Exercise Group
In the treatment group, parents will be instructed to perform postprocedural manipulation after the frenotomy.
Post-frenotomy manual manipulation
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.
Control Group
In the control group, parents will not receive any instructions to perform "suck re-training" exercises or stretching following the procedure.
No interventions assigned to this group
Interventions
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Post-frenotomy manual manipulation
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
90 Days
ALL
No
Sponsors
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Georgetown University
OTHER
Responsible Party
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Earl H. Harley, Jr., MD
Chief of Pediatric Otolaryngology and Professor of Otolaryngology and Pediatrics
Principal Investigators
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Earl H Harley, MD
Role: PRINCIPAL_INVESTIGATOR
MedStar Georgetown University Hospital
Locations
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MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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STUDY00008313
Identifier Type: -
Identifier Source: org_study_id
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