BabyStrong taVNS-Paired Bottle Feeding to Improve Oral Feeding

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 14 days
Maximum Age: 5 months
Healthy Volunteers: f
View:

• 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 has determined will likely need a G-tube.

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Dorothea D. Jenkins, MD
jenkd@musc.edu
843-792-4341
Backup
Troy Huth, JD
huth@musc.edu
843-792-6752
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2024-08-01
Participants
Target number of participants: 20
Treatments
Active_comparator: active taVNS
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.
Sham_comparator: sham taVNS
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.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov