NCT04849507

BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding

BabyStrong taVNS-Paired Bottle Feeding to Improve Oral Feeding

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 2 Weeks – 5 Months
• Healthy volunteers: Not accepted

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.

Detailed description

In this Phase I study, we will conduct a small-scale safety and feasibility study of 2 different taVNS units and ear electrode positions to optimize the BabyStrong portable taVNS feeding system and test the study design of randomization for 10 days. We will test the BabyStrong feeding system using up to n=10 active and n=10 sham taVNS in infants with twice daily treatment for 10 days, with cross over to alternate treatment for another 7days if there is no progress with feeds (increase \<4ml/kg/d). G-tube placement will be arranged if infant continues to make no progress. If the infant attains full oral feeds and gains weight, they may be discharged at any time during the treatment protocol. The treatment assignment will be blinded to care providers, study personnel and parents. We will compare the number of participants who attain full oral feeds (= or \> 130ml/kg/d with weight gain). Safety measures will be bradycardia and discomfort. Criteria for success of BabyStrong feeding system: No sustained increase in discomfort scores; No bradycardia; attainment of full oral feeds in 50% of infants.

Conditions

• Infant Feeding Problems, taVNS

Interventions

Type	Name	Description
DEVICE	transcutaneous auricular vagus nerve stimulation	Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.
DEVICE	Sham transcutaneous auricular vagus nerve stimulation	Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-05-24
• Completion: 2024-08-01
• First posted: 2021-04-19
• Last updated: 2025-10-28
• Results posted: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study