Early Phase 1 N=10 Treatment

NAC +taVNS in IDM Who Are Poor Oral Feeders

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

Bottom Line

View on ClinicalTrials.gov: NCT04632069 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Daily Oral Feeding Volumes : Difference in Mean Increase — 2.1 ml/kg/day po daily change — p=0.009

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: N acetyl cysteine + vagus nerve stimulation (Combination_product)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Mar 2024

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

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.

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

View full record on ClinicalTrials.gov →

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.