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

NCT04849507 | Completed Results DMC FDA Device

• 2 other identifiers: 1088811R41HD104409
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant Feeding Problems, taVNS

Outcome Measures

Primary Outcomes (3)

• Bradycardia

  safety : number of participants with episode of Heart rate \< 80beats per minute for 5 seconds, according to the first assigned treatment

  30 minutes during taVNS paired-feed for 10 days

• Discomfort Scores

  mean number of participants with Neonatal and Infant Pain scale (NIPS) \>3 point increase, indicating worse discomfort according to the first assigned treatment

  30 minutes during taVNS paired-feed up to 17 days

• Participants Who Attain Full Oral Feeds

  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

  17 days

Study Arms (6)

active taVNS cymba to tragus

ACTIVE COMPARATOR

We will deliver taVNS with the ear electrode positioned on left cymba and tragus, with pulses paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) \< perceptual threshold (PT), 500microseconds, 25 Hertz (Hz).The ear electrode will be positioned on left tragus for active taVNS.

Device: transcutaneous auricular vagus nerve stimulation

sham taVNS cymba to tragus

SHAM COMPARATOR

The ear electrode positioned on left cymba and tragus and as for active taVNS. We will test the PT with active stimulation, and then program a sham setting on the BabyStrong unit to deliver no current after the PT is determined.

Device: Sham transcutaneous auricular vagus nerve stimulation

active taVNS cymba to mastoid

ACTIVE COMPARATOR

We will deliver taVNS with the ear electrode positioned on left cymba and mastoid, with pulses paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) \< perceptual threshold (PT), 500microseconds, 25 Hertz (Hz).The ear electrode will be positioned on left tragus for active taVNS.

Device: transcutaneous auricular vagus nerve stimulation

sham taVNS cymba to mastoid

SHAM COMPARATOR

The ear electrode positioned on left cymba and mastoid as for active taVNS. We will test the PT with active stimulation, and then program a sham setting on the BabyStrong unit to deliver no current after the PT is determined.

Device: Sham transcutaneous auricular vagus nerve stimulation

active taVNS cross over to sham

EXPERIMENTAL

infants who received 10 days of active taVNS but had \<4ml/kg/d of oral feeding increase and crossed over the alternative treatment of sham taVNS

Device: transcutaneous auricular vagus nerve stimulation; Device: Sham transcutaneous auricular vagus nerve stimulation

sham taVNS cross over to active taVNS

EXPERIMENTAL

infants who received 10 days of sham taVNS and had \<4ml/kg/d of oral feeding increase and crossed over the alternative treatment of active taVNS

Device: transcutaneous auricular vagus nerve stimulation; Device: Sham transcutaneous auricular vagus nerve stimulation

Interventions

transcutaneous auricular vagus nerve stimulation DEVICE

Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.

Also known as: active taVNS

active taVNS cross over to sham; active taVNS cymba to mastoid; active taVNS cymba to tragus; sham taVNS cross over to active taVNS

Sham transcutaneous auricular vagus nerve stimulation DEVICE

Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding

Also known as: sham taVNS

active taVNS cross over to sham; sham taVNS cross over to active taVNS; sham taVNS cymba to mastoid; sham taVNS cymba to tragus

Eligibility Criteria

• Age: 2 Weeks - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• cardiomyopathy
• unstable bradycardia
• significant respiratory support
• infants of poorly controlled diabetic mothers, defined by obstetrical care providers, HgbA1C\>5.6% or ketonuria.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Limitations and Caveats

small phase I study not powered for statistical analysis; Expected adverse events are reported as safety outcomes (Bradycardia, discomfort increase). There were no unanticipated AEs. Limitations: initial treatment assignment may have an effect that cannot be washed-out by cross-over to the other treatment.

Results Point of Contact

• Title: Dr Dorothea Jenkins
• Organization: Medical University of South Carolina

jenkd@musc.edu

843-792-2112

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: blinded to study treatment assignment to active or sham taVNS. Perceptual threshold (PT) will be determined in both treatment groups.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: If progress in daily oral feeding volumes is \<4ml/kg/d after 10 days with either treatment A or B, we will offer cross-over to the alternate treatment, remaining blinded to treatment assignment.

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: August 1, 2022
• Primary Completion: May 24, 2024
• Study Completion: August 1, 2024
• Last Updated: October 28, 2025
• Results First Posted: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after primary data analysis is complete, pending FDA review
• Access Criteria: We will identify where the data will be available and how to access the data in any publications and presentations that we author or co-author about these data.

Locations

US (1)