Vagus Nerve Stimulation for Improved Breastfeeding in Premature Infants

Overseen By Dorothea Jenkins

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Cardiomyopathy, Unstable bradycardia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help premature or sick infants breastfeed better using a gentle electrical stimulation called taVNS (Transcutaneous Auricular Vagus Nerve Stimulation). Researchers apply this stimulation during breastfeeding to improve infants' latching and sucking skills, aiming to make breastfeeding more effective. Infants who are at least 35 weeks gestational age, stable, and struggling with breastfeeding despite help might be suitable candidates. The goal is to help these babies gain the benefits of breastfeeding and strengthen the bond with their mothers. As an unphased study, this trial offers a unique opportunity for infants to potentially benefit from an innovative approach to improve breastfeeding.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether participants need to stop taking their current medications. However, it focuses on infants and their breastfeeding abilities, so medication changes are unlikely to be required for the infants involved.

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 this technique is safe for infants?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe for infants. In past studies, infants who received taVNS experienced no serious side effects. Experts found that taVNS, a gentle way to stimulate a nerve in the ear, was well-tolerated by infants.

One study showed that using taVNS along with feeding improved infants' feeding skills and was considered safe. Another study found that this method could enhance feeding without causing harm. Overall, the evidence suggests that taVNS is safe for infants and might help them feed more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for improving breastfeeding in premature infants focus on nutritional supplements or adjustments to feeding techniques. However, taVNS (transcutaneous auricular Vagus Nerve Stimulation) offers a novel approach by stimulating the vagus nerve through the ear to enhance feeding capabilities. This non-invasive method could potentially improve muscle coordination and digestion, making feeding easier for premature infants. Researchers are excited about taVNS because it targets the nervous system directly, offering a unique avenue for treatment that could lead to more efficient and effective breastfeeding support for these vulnerable babies.

What evidence suggests that taVNS is effective for improving breastfeeding in premature infants?

Research shows that transcutaneous auricular vagus nerve stimulation (taVNS) might help infants who struggle with breastfeeding. Earlier studies have found that taVNS improves motor skills, which are crucial for feeding. One study discovered that using taVNS during feeding could aid infants with difficulty coordinating mouth movements. Additionally, taVNS has been safely used in infants who might otherwise require more invasive feeding methods, without causing long-term side effects. In this trial, all participants will receive active taVNS during breastfeeding sessions. These findings suggest that taVNS could be a promising method to enhance breastfeeding skills in premature or sick infants. ^{1 4 6 7 8}

Who Is on the Research Team?

Haley Burdge

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for premature infants (≥35 weeks old) in the NICU who are clinically stable and deemed safe to breastfeed. It's also for those not breastfeeding well despite lactation consultant help. Infants with unstable heart rates, significant breathing support needs, or mothers without interest in breastfeeding or with certain health issues can't join.

Inclusion Criteria

Maternal interest in breastfeeding

Deemed safe to breastfeed by OT/SLP/lactation

My baby is at least 35 weeks old, counting from conception.

Exclusion Criteria

Maternal illicit drug use

I need help with breathing.

I have an irregularly slow heartbeat that is not stable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Infants receive daily taVNS treatments paired with breastfeeding for up to 14 days

2 weeks

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including parental satisfaction surveys at 1, 2 weeks, and 3 months

3 months

What Are the Treatments Tested in This Trial?

Interventions

• taVNS

Trial Overview The study tests if taVNS treatments paired with daily breastfeeding can improve feeding skills in premature/sick term infants. The non-invasive device stimulates a nerve during feeds to enhance motor learning, aiming to increase successful breastfeeding at discharge.

How Is the Trial Designed?

Group I: taVNS treatment group Experimental Treatment 1 Intervention

All 10 infants will receive active taVNS during breastfeeding sessions. There is no randomization or blinding involved.

taVNS is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Auricular Vagus Nerve Stimulation for:

• Epilepsy
• Depression
• Obesity

Approved in European Union as Transcutaneous Auricular Vagus Nerve Stimulation for:

• Epilepsy
• Depression

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

In a study of 21 infants with feeding difficulties, those receiving transcutaneous auricular vagus nerve stimulation (taVNS) paired with twice-daily bottle feeding significantly increased their oral feeding volumes compared to their feeding volumes before treatment.

Over 50% of infants receiving twice-daily taVNS achieved full oral feeds in a median of 7 days, which was faster than the 12.5 days for those receiving once-daily taVNS, indicating that more frequent stimulation may enhance feeding outcomes and promote neuroplasticity in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher Dose Noninvasive Transcutaneous Auricular Vagus Nerve Stimulation Increases Feeding Volumes and White Matter Microstructural Complexity in Open-Label Study of Infants Slated for Gastrostomy Tube. Jenkins, DD., Moss, HG., Adams, LE., et al.[2023]

In a study involving at-risk infants receiving transcutaneous auricular vagus nerve stimulation (taVNS) paired with bottle feeding for 2-3 weeks, significant improvements in head movement skills were observed in those who successfully transitioned to full oral feeds, indicating the potential efficacy of taVNS in enhancing motor function.

The study also found that improvements in specific motor skills, such as rolling by arm, were linked to changes in white matter microstructure, suggesting a possible mechanism of action for how taVNS may support motor development in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulation (taVNS) given for poor feeding in at-risk infants also improves their motor abilities. Aljuhani, T., Haskin, H., Davis, S., et al.[2023]

This study will investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on 15 patients with a minimally conscious state, using five different frequencies (1, 10, 25, 50, and 100 Hz) to determine the optimal stimulation parameters.

The goal is to achieve stable improvements in consciousness levels in patients with disorders of consciousness by optimizing the taVNS neuromodulation technique, with results measured through the coma recovery scale-revised (CRS-R) and resting EEG assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the modulation paradigm of transcutaneous auricular vagus nerve stimulation in patients with disorders of consciousness: A prospective exploratory pilot study protocol. Zhai, W., Jiao, H., Zhuang, Y., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (TaVNS) effectively normalized gastric dysrhythmias in healthy individuals during a water-load test, indicating its potential as a treatment for gastric symptoms.

The study found that TaVNS at 40 Hz improved heart rate variability and reduced bloating, suggesting it positively influences both parasympathetic and sympathetic nervous system pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. Du, P., Maharjan, A., Calder, S., et al.[2023]

In a study involving 14 infants at risk of needing G-tube placement, transcutaneous auricular vagus nerve stimulation (taVNS) paired with bottle-feeding rehabilitation was found to be safe and well-tolerated, with no adverse events reported.

57% of the infants achieved adequate oral feeding volumes for discharge without needing a G-tube after an average of 16 days of treatment, indicating that taVNS may effectively improve feeding in infants with oral feeding dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation-Paired Rehabilitation for Oromotor Feeding Problems in Newborns: An Open-Label Pilot Study. Badran, BW., Jenkins, DD., Cook, D., et al.[2023]

In a study of 21 children who were candidates for gastrostomy tubes, those who successfully transitioned to full oral feeding with the help of transcutaneous auricular vagal nerve stimulation (taVNS) showed significantly better sensory processing outcomes compared to those who continued to require G-tubes.

Overall developmental outcomes for both groups were similar to historical controls, indicating that while taVNS may enhance sensory processing, it does not lead to significant differences in other developmental measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of non-invasive transcutaneous auricular vagus nerve stimulation: neurodevelopmental and sensory follow-up. Aljuhani, T., Coker-Bolt, P., Katikaneni, L., et al.[2023]

In a study involving 17 healthy adults, transcutaneous auricular vagus nerve stimulation (taVNS) at the left tragus significantly increased brain activity in areas associated with the vagal pathway, indicating its potential efficacy in neuromodulation.

Compared to control stimulation at the earlobe, tragus stimulation resulted in greater activation in key brain regions, suggesting that taVNS could be a promising therapeutic approach for influencing brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Badran, BW., Dowdle, LT., Mithoefer, OJ., et al.[2020]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improves depression symptoms, as evidenced by reduced scores on the Hamilton Depression Scale in a review of 12 studies involving 838 participants.

taVNS shows comparable response rates to traditional antidepressants and has fewer side effects, suggesting it could be a safe alternative or complementary treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of transcutaneous auricular vagus nerve stimulation in the treatment of depressive disorder: A systematic review and meta-analysis of randomized controlled trials. Tan, C., Qiao, M., Ma, Y., et al.[2023]

Citations

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

Transcutaneous auricular vagus nerve stimulation (taVNS ... Transcutaneous auricular vagus nerve stimulation (taVNS) given for poor feeding in at-risk infants also improves their motor abilities - PMC.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06417385

NCT06417385 | taVNS-Paired Breastfeeding to Improve ... Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve ...

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

Transcutaneous Auricular Vagus Nerve Stimulation-Paired ... taVNS-paired feeding rehabilitation appears safe and may improve oral feeding in infants with oromotor dyscoordination, increasing the rate of discharge ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6536126/

Transcutaneous auricular vagus nerve stimulation (taVNS) ... taVNS produced a mean decrease of 20 ± 9 bpm or 13 ± 5% drop in HR within 20 ± 10 seconds after starting stimulation with feeding (as also seen in healthy adult ...

5. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2023.1297325/full

Use of non-invasive transcutaneous auricular vagus nerve ... Our results suggest that infants who were G-tube candidates and were treated with taVNS paired oral feeding training had no adverse long-term ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7093597/

Transcutaneous Auricular Vagus Nerve Stimulation-Paired ... taVNS-paired feeding rehabilitation appears safe and may improve oral feeding in infants with oromotor dyscoordination, increasing the rate of discharge ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1094715922007644

Transcutaneous Auricular Vagus Nerve Stimulation in ... Compared with invasive vagus nerve stimulation, good safety and tolerability profiles also support the use of tVNS in pediatric patients. Potential ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S002234762300416X

Higher Dose Noninvasive Transcutaneous Auricular Vagus ... All 2x taVNS treated infants significantly increased their feeding volumes compared with 10 days before treatment. Over 50% of 2x taVNS infants achieved full ...