Academy of Breastfeeding Medicine Position Statement on Ankyloglossia in Breastfeeding Dyads.
Yvonne LeFort, Amy Evans, Verity Livingstone...
https://pubmed.ncbi.nlm.nih.gov/33852342Actively 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
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
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
Total: 1 location
1
MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
E
Emily A Clementi, BA
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Yvonne LeFort, Amy Evans, Verity Livingstone...
https://pubmed.ncbi.nlm.nih.gov/33852342Anna H Messner, Jonathan Walsh, Richard M Rosenfeld...
https://pubmed.ncbi.nlm.nih.gov/32283998