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NAC +taVNS in IDM Who Are Poor Oral Feeders

NCT04632069 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-08-29

Study results available
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Summary

Infants of diabetic mothers who are failing to learn oral feeding by term age equivalence have greater CNS oxidative stress, which interact to predict poor neuroplasticity response to transcutaneous vagus nerve stimulation paired with oral feeding. We propose treating the oxidative stress in IDM infants prior to initiating taVNS, with an FDA-approved antioxidant (N-acetylcysteine, NAC) to improve CNS oxidative stress, which in turn regulates expression of many genes including BDNF, that may enhance motor learning.

Conditions

  • Infant of Diabetic Mother
  • Oxidative Stress
  • Vagus Nerve Stimulation
  • Feeding Disorders

Interventions

COMBINATION_PRODUCT

N acetyl cysteine + vagus nerve stimulation

NAC x 14 days, taVNS x 10 days

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Dorothea Jenkins, MD · Medical University of South Carolina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Weeks
Max Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-12
Primary Completion
2024-03-01
Completion
2024-07-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632069 on ClinicalTrials.gov