BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-08-01

Brief Summary

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Feeding is critical for pre-term infants and term infants with hypoxic ischemic brain injury, in order to be discharged home with their families and avoid a gastrostomy tube (G-tube) placement. The proposed study will employ a novel system that stimulates the vagus nerve through the skin in front part of the ear, the BabyStrong feeding system, to delivered transcutaneous auricular vagus nerve stimulation (taVNS) paired with oral feedings daily for 10 days. In an earlier study at Medical University of South Carolina (MUSC), this type of vagus nerve stimulation resulted in more than half of infants who were slated to receive G-tubes, taking full oral feeds by mouth and avoiding a G-tube. In this study some babies will receive the therapy for 10 days and others will get no stimulation. If no progress is made in feeding volumes by day 10, the infants will be switched to the other treatment for 7 days. Parents, study personnel, and care providers will be blinded to taVNS assignment. The electronic stimulation device is Federal Drug Administration (FDA)-cleared for investigational use, and the BabyStrong has been designated a Breakthrough Medical Device by the FDA. This study will be conducted in MUSC's Neonatal Intensive Care Unit.

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Detailed Description

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In this Phase I study, we will conduct a small-scale safety and feasibility study of 2 different taVNS units and ear electrode positions to optimize the BabyStrong portable taVNS feeding system and test the study design of randomization for 10 days. We will test the BabyStrong feeding system using up to n=10 active and n=10 sham taVNS in infants with twice daily treatment for 10 days, with cross over to alternate treatment for another 7days if there is no progress with feeds (increase \<4ml/kg/d). G-tube placement will be arranged if infant continues to make no progress. If the infant attains full oral feeds and gains weight, they may be discharged at any time during the treatment protocol. The treatment assignment will be blinded to care providers, study personnel and parents. We will compare the number of participants who attain full oral feeds (= or \> 130ml/kg/d with weight gain). Safety measures will be bradycardia and discomfort.

Criteria for success of BabyStrong feeding system: No sustained increase in discomfort scores; No bradycardia; attainment of full oral feeds in 50% of infants.

Conditions

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Infant Feeding Problems, taVNS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

If progress in daily oral feeding volumes is \<4ml/kg/d after 10 days with either treatment A or B, we will offer cross-over to the alternate treatment, remaining blinded to treatment assignment.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

blinded to study treatment assignment to active or sham taVNS. Perceptual threshold (PT) will be determined in both treatment groups.

Study Groups

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active taVNS cymba to tragus

We will deliver taVNS with the ear electrode positioned on left cymba and tragus, 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 Type ACTIVE_COMPARATOR

transcutaneous auricular vagus nerve stimulation

Intervention Type DEVICE

Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.

sham taVNS cymba to tragus

The ear electrode positioned on left cymba and tragus and 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.

Group Type SHAM_COMPARATOR

Sham transcutaneous auricular vagus nerve stimulation

Intervention Type DEVICE

Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding

active taVNS cymba to mastoid

We will deliver taVNS with the ear electrode positioned on left cymba and mastoid, 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 Type ACTIVE_COMPARATOR

transcutaneous auricular vagus nerve stimulation

Intervention Type DEVICE

Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.

sham taVNS cymba to mastoid

The ear electrode positioned on left cymba and mastoid 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.

Group Type SHAM_COMPARATOR

Sham transcutaneous auricular vagus nerve stimulation

Intervention Type DEVICE

Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding

active taVNS cross over to sham

infants who received 10 days of active taVNS but had \<4ml/kg/d of oral feeding increase and crossed over the alternative treatment of sham taVNS

Group Type EXPERIMENTAL

transcutaneous auricular vagus nerve stimulation

Intervention Type DEVICE

Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.

Sham transcutaneous auricular vagus nerve stimulation

Intervention Type DEVICE

Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding

sham taVNS cross over to active taVNS

infants who received 10 days of sham taVNS and had \<4ml/kg/d of oral feeding increase and crossed over the alternative treatment of active taVNS

Group Type EXPERIMENTAL

transcutaneous auricular vagus nerve stimulation

Intervention Type DEVICE

Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.

Sham transcutaneous auricular vagus nerve stimulation

Intervention Type DEVICE

Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding

Interventions

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transcutaneous auricular vagus nerve stimulation

Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.

Intervention Type DEVICE

Sham transcutaneous auricular vagus nerve stimulation

Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding

Intervention Type DEVICE

Other Intervention Names

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active taVNS sham taVNS

Eligibility Criteria

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Inclusion Criteria

* Infants born at any gestational age (GA), failing oral feeds after trying to learn feeding for 2 weeks if term, and 4 weeks if preterm
* safe to attempt oral feeds every feed without volume limitations by occupational or speech therapists, and
* clinical team is considering the need for a G-tube.

Exclusion Criteria

* cardiomyopathy
* unstable bradycardia
* significant respiratory support
* infants of poorly controlled diabetic mothers, defined by obstetrical care providers, HgbA1C\>5.6% or ketonuria.

Minimum Eligible Age

2 Weeks

Maximum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No