What side effects are associated with this type of intervention?

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for infant feeding problems has been associated with mild side effects such as a warm sensation, redness, itching, tingling, and muscle spasms. Other common treatments for infant feeding issues include oral and tactile stimulation, which generally have minimal side effects but may cause temporary discomfort or overstimulation in some infants. Massage therapy, another common intervention, has been shown to reduce gastric residual volume and vomiting, with no significant adverse effects reported. Overall, these treatments are considered safe with mild and manageable side effects.

What prior FDA approvals exist?

The BabyStrong feeding system employs Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) to improve oral feeding in infants. While the FDA has cleared the BabyStrong device for investigational use and designated it as a Breakthrough Medical Device, there is no specific mention of prior FDA approvals for similar taVNS treatments for infant feeding problems. Broadly, treatments for infant feeding issues often include nutritional interventions, specialized feeding techniques, and in some cases, pharmacologic agents, but specific FDA-approved neuromodulation devices for this purpose are not well-documented.

What other types of research exist?

One promising alternative to the BabyStrong feeding system for infant feeding problems is the use of an oscillating air mattress. This device has shown effectiveness in reducing apnoeic episodes in preterm infants, which can indirectly support better feeding by improving overall respiratory stability. Another potential alternative is the use of gastric electrical stimulation, which has been effective in treating gastroparesis and could be adapted for infants with severe feeding issues. Both methods represent innovative approaches that could be considered alongside or as alternatives to transcutaneous auricular vagus nerve stimulation.

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Device

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

Q: What is the mechanism of action of this treatment?

The BabyStrong feeding system uses Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) to improve oral feeding in infants by stimulating the vagus nerve through the skin near the ear. This stimulation can enhance the coordination of sucking, swallowing, and breathing, which is crucial for effective feeding. Similar treatments, such as oral and tactile stimulation, work by directly enhancing the sensory and motor functions involved in feeding, thereby improving the infant's ability to suck and swallow. Massage therapy can also aid by reducing gastric residual volume and vomiting, promoting better digestion and feeding tolerance. These mechanisms are vital for infants with feeding problems as they help in developing the necessary skills for effective feeding, potentially reducing the need for interventions like gastrostomy tubes.

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

Must not have

Cardiomyopathy

Unstable bradycardia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes during tavns paired-feed

Summary

This trial tests the BabyStrong system, which gently stimulates a nerve near the ear to help pre-term and brain-injured infants eat better. The goal is to improve their ability to feed by mouth and avoid the need for 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can eat and drink without help or restrictions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with cardiomyopathy.

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I have an irregularly slow heartbeat that changes often.

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I need help with breathing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes during tavns paired-feed

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

bradycardia

discomfort scores

increase in oral feeding volumes

Secondary study objectives

white matter tract neuroplasticity

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The BabyStrong feeding system uses Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) to improve oral feeding in infants by stimulating the vagus nerve through the skin near the ear. This stimulation can enhance the coordination of sucking, swallowing, and breathing, which is crucial for effective feeding. Similar treatments, such as oral and tactile stimulation, work by directly enhancing the sensory and motor functions involved in feeding, thereby improving the infant's ability to suck and swallow. Massage therapy can also aid by reducing gastric residual volume and vomiting, promoting better digestion and feeding tolerance. These mechanisms are vital for infants with feeding problems as they help in developing the necessary skills for effective feeding, potentially reducing the need for interventions like gastrostomy tubes.

Coordination of sucking, swallowing and breathing in the newborn: its relationship to infant feeding and normal development.Nutritive sucking in high-risk neonates after perioral stimulation.Effectiveness of multistimulation approach on feeding habits of low-birth-weight babies-A randomized control trial.