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

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Infant Feeding Problems, taVNS

Treatments

Device: transcutaneous auricular vagus nerve stimulation

Device: Sham transcutaneous auricular vagus nerve stimulation

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04849507

108881

1R41HD104409 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

17 patients

Sex

All

Ages

2 weeks to 5 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

17 participants in 6 patient groups

active taVNS cymba to tragus

Active Comparator group

Description:

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.

Treatment:

Device: transcutaneous auricular vagus nerve stimulation

sham taVNS cymba to tragus

Sham Comparator group

Description:

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.

Treatment:

Device: Sham transcutaneous auricular vagus nerve stimulation

active taVNS cymba to mastoid

Active Comparator group

Description:

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.

Treatment:

Device: transcutaneous auricular vagus nerve stimulation

sham taVNS cymba to mastoid

Sham Comparator group

Description:

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.

Treatment:

Device: Sham transcutaneous auricular vagus nerve stimulation

active taVNS cross over to sham

Experimental group

Description:

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

Treatment:

Device: Sham transcutaneous auricular vagus nerve stimulation

Device: transcutaneous auricular vagus nerve stimulation

sham taVNS cross over to active taVNS

Experimental group

Description: