Clinical Consensus Statement: Ankyloglossia in Children.
Anna H Messner, Jonathan Walsh, Richard M Rosenfeld...
https://pubmed.ncbi.nlm.nih.gov/32283998/Actively Recruiting
Led by Georgetown University · Updated on 2025-02-17
110
Participants Needed
1
Research Sites
4 weeks
Total Duration
This trial studies infants with ankyloglossia, commonly known as tongue-tie, to see if doing manual tongue exercises after a frenotomy a procedure to release the tongue can reduce the need for repeat procedures and improve breastfeeding. The research aims to compare outcomes between babies who do these exercises after surgery and those who do not. The study is a randomized controlled trial led by Georgetown University, focusing on how manual manipulation may affect tongue healing and feeding success. Infants under 90 days old who have a frenotomy with cold-steel scissors and are at least partly breastfed are randomly assigned to one of two groups. In the treatment group, parents will perform tongue stretching and suck re-training exercises four times a day for 2 to 3 weeks, starting 24 hours after the procedure. The control group will not receive instructions for any exercises. Follow-ups include a phone call one week after surgery and an in-person visit 2 to 3 weeks after to review breastfeeding and any need for further frenotomy. During the study, researchers will track how well parents follow the exercise plan and monitor any problems through the phone follow-up. At the in-person visit, they will evaluate breastfeeding performance and determine if another frenotomy is needed. The main outcomes measured are the rate of repeat frenotomies and improvements in breastfeeding from the time of enrollment to the postoperative visit. Participation lasts about 2 to 3 weeks after the procedure.
CONDITIONS
Post-Procedural Manual Manipulation for Infant Ankyloglossia
E
Emily A Clementi, BA
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Georgetown University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Manual manipulation (parent-performed exercises) after frenotomy | No manual manipulation after frenotomy |
|---|---|---|
| What it is | Parents perform tongue stretches and exercises after frenotomy, four times daily, until the postoperative visit (2-3 weeks later). | No post-frenotomy exercises or manual tongue manipulation are performed. Routine post-procedure observation only. |
| Role in trial | Investigational intervention aimed at reducing repeat frenotomy and enhancing breastfeeding outcomes. | Comparator group; assesses outcomes with standard observation following frenotomy without exercises. |
| Primary use/clinical purpose | Test whether parent-performed tongue exercises after frenotomy can reduce the likelihood of repeat frenotomy and improve breastfeeding for infants with ankyloglossia. | Evaluate outcomes of infants with ankyloglossia undergoing frenotomy without any post-procedural exercises, representing standard observation practice. |
| How it is given/performed | Parents perform stretches and exercises four times a day, after every other feed, for 2-3 weeks following frenotomy. | No exercises or stretches are directed; infants are monitored until the postoperative visit. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 to 3 weeks
Participants who undergo frenotomy will either perform or not perform post-procedural manual manipulation exercises as instructed.
1 postoperative visit and 1 follow-up phone call
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Anna H Messner, Jonathan Walsh, Richard M Rosenfeld...
https://pubmed.ncbi.nlm.nih.gov/32283998/Yvonne LeFort, Amy Evans, Verity Livingstone...
https://pubmed.ncbi.nlm.nih.gov/33852342/Georgetown University
Lead Sponsor