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NCT06830148 · ClinicalTrials.gov registry record · NA
Post-Procedural Manual Manipulation for Infant Ankyloglossia
A NA study of Breastfeeding Support and Ankyloglossia, sponsored by Georgetown University.
- Recruiting
- Registry status
- NA
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT06830148 is a NA study of Breastfeeding Support and Ankyloglossia that is actively recruiting participants, run by Georgetown University. The registered enrollment target is 110 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06830148, a NA study of Breastfeeding Support and Ankyloglossia, is actively recruiting participants, sponsored by Georgetown University.
- RECRUITING
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER Post-frenotomy manual manipulation
Study Locations (1)
District of Columbia
- MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2024-10-15 |
| Est. Completion | 2025-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06830148
The ClinicalTrials.gov registry entry for NCT06830148 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breastfeeding Support appearing as the primary indexed condition, and to 1 intervention - of which Post-frenotomy manual manipulation is the first listed.
NCT06830148 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06830148 about?
NCT06830148 is a clinical study titled "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, th...
What is the current status of trial NCT06830148?
This trial is currently recruiting. It is a NA study. The enrollment target is 110 participants. The study started on 2024-10-15. Estimated completion is 2025-11.
What conditions does trial NCT06830148 study?
This clinical trial studies the following conditions: Breastfeeding Support, Ankyloglossia.
What interventions are being tested in trial NCT06830148?
The interventions under investigation include: Post-frenotomy manual manipulation (OTHER).
Who is sponsoring clinical trial NCT06830148?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06830148 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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