Manual manipulation after frenotomy for infants with tongue tie
Effectiveness of Post-Procedural Manual Manipulation for Infant Ankyloglossia in Enhancing Breastfeeding and Reducing Revision Rates: A Prospective Randomized Trial
This study is testing if tongue stretching and suck re-training exercises after a tongue tie surgery can help infants breastfeed better and prevent the tongue tie from coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | N/A to 90 Days |
| Sex | All |
| Sponsor | Georgetown University Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06830148 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of post-frenotomy manual manipulation in infants diagnosed with ankyloglossia. Infants undergoing frenotomy will be randomly assigned to either an intervention group, which will perform tongue stretching and suck re-training exercises, or a control group with no intervention. The study will assess the impact of these exercises on the rates of frenulum regrowth and breastfeeding outcomes. Follow-up assessments will be conducted to monitor adherence and any complications.
Who should consider this trial
Good fit: Ideal candidates are infants under 90 days old with ankyloglossia who are exclusively or partially breastfed.
Not a fit: Patients who are older than 90 days, exclusively bottle-fed, or have undergone previous frenotomy procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve breastfeeding outcomes for infants with ankyloglossia.
How similar studies have performed: While similar approaches have been explored, this specific intervention's effectiveness remains to be fully validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington D.C., District of Columbia
- MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Earl H Harley, MD — MedStar Georgetown University Hospital
- Study coordinator: Emily A Clementi, BA
- Email: eac166@georgetown.edu
- Phone: (202) 444-8186
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.