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Device

taVNS Paired Bottle Feeding for Infant Feeding Problems (BabyStrong I Trial)

Phase 1
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Safe to attempt oral feeds every feed without volume limitations by occupational or speech therapists
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes during tavns paired-feed
Awards & highlights

BabyStrong I Trial Summary

This trial will test a new system that stimulates the vagus nerve to see if it helps pre-term infants and infants with brain injury to be able to eat and avoid a feeding tube.

Who is the study for?
This trial is for infants with feeding problems who may need a G-tube. It includes those born at any gestational age, struggling with oral feeds after 2 weeks (if term) or 4 weeks (if preterm), and deemed safe for unrestricted oral feeding attempts by therapists. Infants with cardiomyopathy, unstable bradycardia, significant respiratory support needs, or born to mothers with poorly controlled diabetes are excluded.Check my eligibility
What is being tested?
The study tests a novel BabyStrong system that stimulates the vagus nerve in the ear to improve bottle feeding in infants over 10 days. Some babies will receive this stimulation while others won't; non-responders switch treatments after day 10. The device used is FDA-cleared for research and considered a Breakthrough Medical Device.See study design
What are the potential side effects?
Specific side effects of transcutaneous auricular vagus nerve stimulation aren't detailed here but could include discomfort at the stimulation site or changes in heart rate or breathing patterns due to vagus nerve's broad influence.

BabyStrong I Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can eat and drink without help or restrictions.

BabyStrong I Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes during tavns paired-feed
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes during tavns paired-feed for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
bradycardia
discomfort scores
increase in oral feeding volumes
Secondary outcome measures
white matter tract neuroplasticity

BabyStrong I Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: active taVNSActive Control1 Intervention
We will deliver taVNS via the BabyStrong system, 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.
Group II: sham taVNSPlacebo Group1 Intervention
The ear electrode positioned on left tragus 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.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,615 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,777 Total Patients Enrolled

Media Library

BabyStrong feeding system (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04849507 — Phase 1
Infant Feeding Problems Research Study Groups: active taVNS, sham taVNS
Infant Feeding Problems Clinical Trial 2023: BabyStrong feeding system Highlights & Side Effects. Trial Name: NCT04849507 — Phase 1
BabyStrong feeding system (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04849507 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this experiment?

"Affirmative. The clinical trial registry displays that this medical experiment, initially advertised on August 1st 2022, is currently recruiting subjects. It seeks 20 volunteers from a single site."

Answered by AI

Am I eligible to join this clinical experiment?

"To be considered for this research study, applicants must have a medical diagnosis of brain ischemia and fall within the 2 week to 5 month age range. As of now, there are 20 open spots available."

Answered by AI

Are there ongoing opportunities for volunteers to partake in the trial?

"As stated on clinicaltrials.gov, this research is currently recruiting candidates with the initial posting date of August 1st 2022 and most recent edits made just two days ago."

Answered by AI

Has transcutaneous vagus nerve stimulation obtained FDA authorization?

"The safety of taVNS is ranked a 1 on our evaluation scale given that this particular trial has only produced limited data regarding efficacy and security."

Answered by AI

Is this experimental research enrolling individuals aged 40 or above?

"The trial is open to children between 2 weeks and 5 months of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding
Dorothea D. Jenkins 2022. "BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04849507.
~7 spots leftby Apr 2025
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