CompletedEarly Phase 1

NAC +taVNS in IDM Who Are Poor Oral Feeders

United States10 participantsStarted 2021-08-12

Plain-language 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.

Who can participate

Age range3 Weeks – 5 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Daily Oral Feeding Volumes : Difference in Mean Increase

Timeframe: Day -14 to 0, Day 1 to 18

Trial details

NCT IDNCT04632069

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-01

Results submitted2024-04-18

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