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

Phase

N/A

Condition

N/A

Treatment

Sham transcutaneous auricular vagus nerve stimulation

transcutaneous auricular vagus nerve stimulation

Clinical Study ID

NCT04849507

108881

1R41HD104409

Ages 2-5
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Sham transcutaneous auricular vagus nerve stimulation

August 01, 2022

August 01, 2024

Study 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.

Connect with a study center

Medical University of South Carolina
Charleston, South Carolina 29425
United States
Site Not Available
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
United States
Site Not Available

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