taVNS for Feeding Issues in Newborns

(BabySTrong II Trial)

Overseen By Gary Connor, RN

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Medical University of South Carolina

Disqualifiers: Cardiomyopathy, Unstable apnea, Respiratory support, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 14-24 days

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist newborns with brain injuries who struggle with feeding, potentially reducing the need for feeding tubes. It tests a new therapy called the BabySTrong taVNS Feeding System, which uses gentle nerve stimulation at the ear to enhance feeding skills. The trial includes several groups: one for infants of diabetic mothers receiving both a supplement and active nerve stimulation, and others receiving either active or inactive stimulation. Infants over 39 weeks old who have been trying to feed for at least two to four weeks with little progress might be suitable for this trial. As a Phase 2, Phase 3 trial, this research evaluates the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering hope for effective feeding solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the BabySTrong taVNS Feeding System is safe for infants?

Research shows that the BabySTrong taVNS Feeding System is generally safe for babies. Studies have demonstrated that transcutaneous auricular vagus nerve stimulation (taVNS) improves feeding skills in at-risk infants without causing serious side effects. For instance, one study found that 58% of infants using taVNS could feed fully by mouth, indicating that the treatment is well-tolerated. Daily stimulation of the vagus nerve, a component of this treatment, has been safely used in both adults and infants to aid the brain in learning tasks like feeding. While the treatment appears promising, ongoing research aims to confirm its safety and effectiveness in this specific area. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the BabySTrong taVNS Feeding System because it offers a novel approach to addressing feeding issues in newborns. Unlike standard treatments, which often rely on more invasive methods like feeding tubes or medications, this system uses transcutaneous auricular vagus nerve stimulation (taVNS) paired with oral feedings. This non-invasive technique may enhance feeding by stimulating the vagus nerve, potentially improving swallowing and digestion. Additionally, for infants of diabetic mothers, the combination with N-acetylcysteine (NAC) could provide added benefits by reducing oxidative stress. This innovative approach could lead to quicker and safer improvements in feeding for newborns.

What evidence suggests that the BabySTrong taVNS Feeding System is effective for feeding issues in newborns?

Research has shown that the BabySTrong taVNS Feeding System might assist babies with eating difficulties. In early studies, 54% of babies with feeding delays ate all their food by mouth within two weeks of using this system, without needing feeding tubes. Even those who did not achieve full oral feeding consumed more each day. In this trial, some infants will receive active taVNS, while others will receive inactive/sham taVNS as part of different treatment arms. The treatment appears to strengthen the brain's feeding-related circuits, suggesting that using taVNS during feeding could be a promising method for babies who struggle to eat. ^{1 2 4 6 7}

Who Is on the Research Team?

Dorothea D JENKINS, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

The BabySTrong II taVNS Feeding Trial is for pre-term and term infants with brain injury who are struggling to learn how to feed properly. Infants considered for a gastrostomy tube (G-tube) or prolonged home nasogastric feeding due to failure to thrive may be eligible.

Inclusion Criteria

My baby is over 39 weeks post-menstrual age and struggles with feeding.

I have been learning to feed for the required time based on when I started.

I can eat and drink without needing help or having limits on how much.

Exclusion Criteria

Significant respiratory support (CPAP/Vapotherm)

Congenital syndromes unlikely to orally feed

I have been diagnosed with cardiomyopathy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants receive active or sham taVNS paired with oral feedings for 14 days, with potential open-label extension for up to 10 additional days

14-24 days

Daily visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neuroplasticity assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BabySTrong taVNS Feeding System

Trial Overview This trial tests the BabySTrong taVNS feeding system, which combines non-invasive vagus nerve stimulation at the ear (taVNS) with feeding motor skills training. The goal is to improve daily feeding volumes, reduce time to full oral feeds, and avoid G-tube/home NG placement.

How Is the Trial Designed?

Group I: IDM NAC and active taVNS Active Control 1 Intervention

Infants of diabetic mothers will receive N-acetylcysteine by NG tube every 6h and active taVNS paired with 2 oral feedings a day, as a drug and device combination treatment for 14 days.

Group II: Non-IDM active taVNS Active Control 1 Intervention

Non-IDM (Infants not product of diabetic mothers) will receive active taVNS with 2 feeds/day x 14 days

Group III: Non-IDM Control Placebo Group 1 Intervention

Non-IDM (Infants not product of diabetic mothers) will receive inactive/sham taVNS paired with 2 oral feedings a day for 14 days.

Group IV: IDM Control Placebo Group 1 Intervention

Infants of diabetic mothers will receive sterile water and inactive taVNS paired with 2 oral feedings a day, as a placebo drug and sham device combination treatment, for 14 days.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07049952

NCT07049952 | BabySTrong II taVNS Feeding Trial The long-term goal of this project is to develop a therapy to assist pre-term and term infants with brain injury overcome difficulties in learning to feed.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9976577/

Transcutaneous auricular vagus nerve stimulation (taVNS ... CONCLUSION: These results suggest that pairing feeding with taVNS may affect specific head and neck movements to a greater extent in infants ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/07/NCT04849507/Prot_001.pdf

BabyStrong taVNS-Paired Bottle Feeding to Improve Oral ... In a recent Neonatal Research Network study, 37% of 6017 moderately preterm infants remain hospitalized beyond 36 weeks GA due to feeding difficulty 2. These ...

4. withpower.com withpower.com/trial/phase-2-and-3-feeding-delays-8-2025-60161

taVNS for Feeding Issues in Newborns (BabySTrong II Trial) In our pilot studies, 54% (19 out of 35) infants with feeding delays whose families were in discussions for G-tube placement, reached full oral feeds within 2 ...

5. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2020.00077/full

Transcutaneous Auricular Vagus Nerve Stimulation-Paired ... In infants who had failed oromotor rehabilitative feeding techniques by therapists, taVNS treatments resulted in 57% achieving full oral feeds adequate for ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/07/NCT04849507/ICF_000.pdf

BabyStrong taVNS-Paired Bottle Feeding to Improve Oral ... A course of daily vagal nerve stimulation has been shown to be safe and to help the brain learn motor tasks in adults and in our study of ...

7. research.aota.org research.aota.org/ajot/article/74/4_Supplement_1/7411520479p1/9738/Transcutaneous-Auricular-Vagus-Nerve-Stimulation

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS ... With taVNS, 58% successfully attained full oral feeds (responders) vs 42% who received gastrostomy feeding tube (non-responders). For a ...