Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Completed
NCT Number: NCT04849507
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding
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.
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Conditions
Age range
2 week–5 month
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Infants born at any gestational age (GA), failing oral feeds after trying to learn feeding for 2 weeks if term, and 4 weeks if preterm
- safe to attempt oral feeds every feed without volume limitations by occupational or speech therapists, and
- clinical team is considering the need for a G-tube.
Exclusion criteria
- cardiomyopathy
- unstable bradycardia
- significant respiratory support
- infants of poorly controlled diabetic mothers, defined by obstetrical care providers, HgbA1C>5.6% or ketonuria.
Treatment and study plan
Transcutaneous Auricular Vagus Nerve Stimulation
DeviceStimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.
Other names: active taVNS
Sham transcutaneous auricular vagus nerve stimulation
DeviceSham stimulation of the left auricular branch of the vagus nerves paired with oral feeding
Other names: sham taVNS
Primary outcomes
-
Bradycardia
Time frame: 30 minutes during taVNS paired-feed for 10 days
safety : number of participants with episode of Heart rate < 80beats per minute for 5 seconds, according to the first assigned treatment
-
Discomfort Scores
Time frame: 30 minutes during taVNS paired-feed up to 17 days
mean number of participants with Neonatal and Infant Pain scale (NIPS) >3 point increase, indicating worse discomfort according to the first assigned treatment
-
Participants Who Attain Full Oral Feeds
Time frame: 17 days
taVNS in participants who received tragus stimulation and attained full oral feeds (oral intake = or >130ml/kg/day with weight gain) according to the first assigned treatment
Sponsors and collaborators
Lead sponsor
Medical University of South Carolina
Other
Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Registry information
Official study title
BabyStrong taVNS-Paired Bottle Feeding to Improve Oral Feeding
Acronym: BabyStrong I
Important dates
- Study start
- 2022
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Apr 19, 2021
- Registry last updated
- Oct 28, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.