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

Trial Summary

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 data supports the idea that Vagus Nerve Stimulation for Improved Breastfeeding in Premature Infants is an effective treatment?

The available research shows that Vagus Nerve Stimulation (taVNS) can be effective for improving breastfeeding in premature infants. In one study, 57% of infants who received taVNS paired with bottle-feeding were able to achieve adequate feeding volumes for discharge without needing a feeding tube. This suggests that taVNS may help improve oral feeding skills in infants who struggle with feeding, potentially reducing the need for surgical interventions like gastrostomy tubes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment taVNS for improving breastfeeding in premature infants?

Research suggests that taVNS, when paired with bottle-feeding, may help improve feeding volumes in infants who struggle with oral feeding, potentially avoiding the need for a feeding tube. In a study, 57% of infants receiving taVNS achieved adequate feeding volumes for discharge without needing a gastrostomy tube. ^{1 2 3 4 5}

What safety data exists for transcutaneous auricular vagus nerve stimulation (taVNS)?

A systematic review and meta-analysis of 177 studies involving 6322 subjects found that taVNS is generally safe, with mild and transient adverse effects such as ear pain, headache, and tingling. The incidence of adverse events was low, at 12.84 per 100,000 person-minutes-days of stimulation, and there was no increased risk of adverse events compared to controls. No severe adverse events were causally linked to taVNS, making it a safe and feasible option for clinical intervention. ^{3 5 6 7 8}

Is transcutaneous auricular vagus nerve stimulation (taVNS) safe for humans?

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe, with mild and temporary side effects like ear pain, headache, and tingling. A large review found no serious adverse events linked to taVNS, making it a safe option for clinical use. ^{3 5 6 7 8}

Is the treatment taVNS promising for improving breastfeeding in premature infants?

Yes, taVNS is a promising treatment for improving breastfeeding in premature infants. It has been shown to increase feeding volumes, improve motor skills, and help infants avoid the need for a feeding tube, making it easier for them to be discharged from the hospital. ^{1 2 4 5 9}

How is the treatment taVNS different from other treatments for improving breastfeeding in premature infants?

taVNS is unique because it is a non-invasive treatment that uses electrical stimulation on the ear to improve feeding skills in premature infants. Unlike other treatments that might require surgery, such as a gastrostomy tube, taVNS is paired with bottle feeding to enhance oromotor coordination and increase feeding volumes, potentially avoiding the need for surgical interventions. ^{1 2 4 5 9}

What is the purpose of this trial?

Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation. Investigators will recruit 10 premature, ≥ 35 weeks gestational age, or convalescing sick term infants admitted to the NICU at MUSC to participate in this study. Infants will receive taVNS treatments once a day with breastfeeding's for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort, and during daily treatment paired with breastfeeding the infant will continue to receive this level of electrical stimulation, coinciding with latching and sucking, repeated over the duration of the feed. Investigators will collect information about the pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow techniques by the infant from parents and the lactation consultant. Investigators will also evaluate parental satisfaction associated with their infant's ability to breastfeed after taVNS by providing parental satisfaction surveys at the beginning, after 1 and 2 weeks, and at 3 months after the end of the study to assess infants' progress in and maintenance of breastfeeding abilities. If the pairing of breastfeeding with taVNS is able to result in improved outcomes of effective breastfeeding in infants in the neonatal intensive care units, this intervention could be further utilized by NICUs to increase the rate of premature and sick term infants who are successfully able to breastfeed at the time of discharge and maintain breast feeding longer after discharge. This would allow premature infants to acquire the many benefits of breastmilk as well as contribute towards the strengthening of the maternal-infant bond that breastfeeding has been shown to enhance.

Research Team

Haley Burdge

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

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

Deemed safe to breastfeed by OT/SLP/lactation

Exclusion Criteria

Maternal illicit drug use

I need help with breathing.

I have an irregularly slow heartbeat that is not stable.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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) 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]

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]

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]

References

1. United States 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation-Paired Rehabilitation for Oromotor Feeding Problems in Newborns: An Open-Label Pilot Study. [2023]

3. Switzerland 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. [2023]

4. United States 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. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulation (taVNS) given for poor feeding in at-risk infants also improves their motor abilities. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. [2023]

8. Netherlands 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. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Use of non-invasive transcutaneous auricular vagus nerve stimulation: neurodevelopmental and sensory follow-up. [2023]