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Antioxidant
NAC + taVNS for Feeding Disorders in Infants of Diabetic Mothers
Phase < 1
Waitlist Available
Led By Dorothea Jenkins, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 days
Awards & highlights
Study Summary
This trial suggests that treating infants of diabetic mothers with an antioxidant may help improve their motor learning.
Who is the study for?
This trial is for infants born to diabetic mothers who are over 39 weeks gestation, struggling with oral feeding, and considered stable enough for minimal respiratory support. It's not suitable for those under 39 weeks gestation, with major congenital anomalies affecting feeding, unstable conditions requiring advanced respiratory support, heart muscle issues or frequent episodes of apnea/bradycardia.Check my eligibility
What is being tested?
The study tests if an antioxidant called N-acetylcysteine (NAC) can reduce brain oxidative stress in these infants before starting transcutaneous vagus nerve stimulation (taVNS), which is paired with oral feeding to enhance motor learning and improve their ability to feed orally.See study design
What are the potential side effects?
Potential side effects from the intervention may include irritation at the site of taVNS application and possible reactions to NAC such as rash, fever or liver enzyme changes. However, specific side effects will be monitored closely given the vulnerable population.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Daily oral feeding volumes
Secondary outcome measures
Metabolite concentrations in basal ganglia
Other outcome measures
Diffusion Kurtosis Imaging (DKI)
Trial Design
1Treatment groups
Experimental Treatment
Group I: NAC + taVNSExperimental Treatment1 Intervention
NAC will be given via nasogastric tube (n,g.) 100mg/kg loading dose, then 75mg/kg/dose n.g. q 6h, administered 1h before a feed, for a total of 14 days. taVNS will be administered to left ear during active sucking with 2 daily feedings starting after 4 days of NAC, continuing for 10 days.
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,380 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
248,750 Total Patients Enrolled
Dorothea Jenkins, MDPrincipal InvestigatorMedical University of South Carolina
2 Previous Clinical Trials
65 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant has been diagnosed with cardiomyopathy.I have birth defects that affect my ability to eat properly.My baby was born before 39 weeks of pregnancy.My baby, born at full term from a diabetic mother, struggles with feeding, is stable but needs minimal breathing support, and may need a feeding tube.My infant needs help with breathing or is not stable.You have experienced multiple episodes of autonomic instability (such as breathing pauses and slow heart rate) that did not go away on their own.
Research Study Groups:
This trial has the following groups:- Group 1: NAC + taVNS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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