Status:
COMPLETED
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infant Feeding Problems, taVNS
Eligibility:
All Genders
2-5 years
Phase:
NA
Brief 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 pr...
Detailed 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 te...
Eligibility Criteria
Inclusion
- 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
- cardiomyopathy
- unstable bradycardia
- significant respiratory support
- infants of poorly controlled diabetic mothers, defined by obstetrical care providers, HgbA1C\>5.6% or ketonuria.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04849507
Start Date
August 1 2022
End Date
August 1 2024
Last Update
October 28 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425