Post-Procedural Manual Manipulation for Infant Ankyloglossia

Launched by GEORGETOWN UNIVERSITY · Feb 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a specific technique called post-frenotomy manual manipulation can help improve breastfeeding outcomes for infants with a condition known as ankyloglossia, which is often referred to as "tongue tie." After a minor procedure called frenotomy, where the tight band of tissue under the tongue is cut to help with breastfeeding, some infants may experience regrowth of this tissue. The trial aims to see if doing tongue stretching and suck training exercises at home can reduce this regrowth and improve how well babies breastfeed.

Infants who are less than 90 days old and have ankyloglossia may be eligible for the study if they will be breastfed. Participants will be randomly assigned to either a group that practices these exercises or a group that does not. Families in the exercise group will be guided to perform the exercises several times a day for 2-3 weeks after the procedure. Researchers will check in with families by phone a week later and will have an in-person follow-up after a few weeks to see how breastfeeding is going and if any further procedures are needed. This study is currently looking for participants, and it's open to all genders.

Gender

ALL

Eligibility 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