BabySTrong II taVNS Feeding Trial

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial, called the BabySTrong II taVNS Feeding Trial, is studying a new way to help babies who have trouble learning to feed by mouth, especially those born early or with brain injuries. Feeding by mouth is very important for babies to go home from the hospital without needing special feeding tubes. The study is testing a gentle, non-invasive device that sends small electrical signals to a nerve in the ear (called vagus nerve stimulation) while the baby is being bottle-fed. Early tests showed that over half of the babies who might have needed feeding tubes were able to fully feed by mouth within two weeks using this approach, and even those who didn’t fully feed improved their eating amounts.

Babies who are eligible for the study are those around full-term age (about 39 weeks or older) who have been trying to feed by mouth for at least 2 to 4 weeks but are still making only slow progress. Babies with serious heart problems, unstable breathing, or certain major health issues won’t be able to join. If a baby joins the study, parents can expect that the feeding therapy will involve using this new device during regular bottle feedings in the hospital. The trial will compare this new method to standard care to see if it helps babies feed better, avoid feeding tubes, and leave the hospital sooner. If successful, this could make a big difference for families by reducing feeding struggles and hospital time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • infants \>39 weeks PMA making minimal progress in oral feeds
• • trying to learn feeding for at least 2wks if beginning feeds at term (\>37wks PMA), and 4wks if beginning feeds \<36wks PMA,
• • may po every feed without volume limitations by therapists
• Exclusion Criteria:
• • cardiomyopathy
• • unstable apnea/bradycardia
• • significant respiratory support (CPAP/ Vapotherm)
• • unrepaired major congenital anomalies that affect safe po feeding or impose volume restrictions
• • congenital syndromes unlikely to orally feed