Early Phase 1
Completed N=10
NAC +taVNS in IDM Who Are Poor Oral Feeders
Infant of Diabetic Mother · oxidative stress · Vagus Nerve Stimulation · Feeding Disorders
Source: ClinicalTrials.gov NCT04632069 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Daily Oral Feeding Volumes : Difference in Mean Increase — 2.1 ml/kg/day po daily change — p=0.009
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Oral Feeding Volumes : Difference in Mean Increase |
2.1 | 0.009 sig |
| SECONDARY Metabolite Concentrations in Basal Ganglia |
0.13 | 0.01 sig |
Eligibility Criteria
Inclusion Criteria
- Infants of diabetic mothers who are failing oral feeding, >39weeks gestation at enrollment, who are clinically stable, on minimal respiratory support (nasal cannula or room air), and clinical team has determined are G-tube candidates
Exclusion Criteria
- Unstable infants or those requiring positive pressure respiratory support
- Infants <39 weeks gestation at enrollment
- Major unrepaired congenital anomalies or anomalies that limit feeding volumes
- Infants with cardiomyopathy
- Repeated episodes of autonomic instability (apnea/ bradycardia) not self resolving
Data sourced from ClinicalTrials.gov (NCT04632069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.