At a glance
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N-acetylcysteine Plus Transcutaneous Vagus Nerve Stimulation in Infants of Diabetic Mothers Who Fail Oral Feeding
In Brief
A Early Phase 1 clinical trial evaluating N acetyl cysteine + vagus nerve stimulation for Infant of Diabetic Mother and 3 related conditions. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
NAC x 14 days, taVNS x 10 days