At a glance
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BabyStrong taVNS-Paired Bottle Feeding to Improve Oral Feeding
In Brief
A clinical study evaluating transcutaneous auricular vagus nerve stimulation and Sham transcutaneous auricular vagus nerve stimulation for Infant Feeding Problems, taVNS. Completed, enrolled 17 participants across 1 site.
Detailed Summary
Feeding is critical for pre-term infants and term infants with hypoxic ischemic brain injury, in order to be discharged home with their families and avoid a gastrostomy tube (G-tube) placement. The proposed study will employ a novel system that stimulates the vagus nerve through the skin in front part of the ear, the BabyStrong feeding system, to delivered transcutaneous auricular vagus nerve stimulation (taVNS) paired with oral feedings daily for 10 days. In an earlier study at Medical University of South Carolina (MUSC), this type of vagus nerve stimulation resulted in more than half of infants who were slated to receive G-tubes, taking full oral feeds by mouth and avoiding a G-tube. In this study some babies will receive the therapy for 10 days and others will get no stimulation. If no progress is made in feeding volumes by day 10, the infants will be switched to the other treatment for 7 days. Parents, study personnel, and care providers will be blinded to taVNS assignment. The electronic stimulation device is Federal Drug Administration (FDA)-cleared for investigational use, and the BabyStrong has been designated a Breakthrough Medical Device by the FDA. This study will be conducted in MUSC's Neonatal Intensive Care Unit.
Study Details
Timeline
Interventions
Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.
Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding