What is the mechanism of action of this treatment?

Common treatments for Feeding Disorders often involve the use of antioxidants like N-acetylcysteine (NAC), ascorbic acid, and omega-3 fatty acids. These treatments work by reducing oxidative stress in the central nervous system (CNS), which is crucial because oxidative stress can impair brain function and neuroplasticity. NAC, for example, helps to regulate the expression of genes such as brain-derived neurotrophic factor (BDNF), which is essential for motor learning and synaptic plasticity. By mitigating oxidative damage and enhancing gene expression, these treatments can improve feeding behaviors and overall brain health in patients with Feeding Disorders.

What side effects are associated with this type of intervention?

Common treatments for feeding disorders, particularly those involving antioxidants like N-acetylcysteine (NAC), aim to reduce oxidative stress and improve motor learning. NAC is generally well-tolerated but can cause side effects such as gastrointestinal disturbances (nausea, vomiting, diarrhea), rash, and, rarely, anaphylactic reactions. Other treatments for feeding disorders may include dietary modifications and behavioral interventions, which typically have minimal side effects but require consistent adherence and monitoring.

What prior FDA approvals exist?

The FDA has approved various treatments for feeding disorders, though specific approvals for antioxidants like N-acetylcysteine (NAC) are limited. NAC is being studied for its potential to reduce CNS oxidative stress and enhance motor learning by regulating gene expression, including BDNF. While there are no direct FDA approvals for NAC in feeding disorders, other antioxidants such as vitamin E have been explored for their neuroprotective effects in different contexts. Overall, the use of antioxidants in treating feeding disorders remains an area of active research rather than established FDA-approved therapy.

What other types of research exist?

Based on the provided context, there are no specific novel alternatives to N-acetylcysteine (NAC) mentioned for treating feeding disorders by reducing CNS oxidative stress and regulating gene expression, including BDNF. However, other antioxidants like Vitamin E and Omega-3 fatty acids have been studied for their neuroprotective effects and could be considered as potential alternatives. It is important to consult with a healthcare provider to explore these options and any new emerging treatments in 2024.

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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

Must not have

Infants with cardiomyopathy

Major unrepaired congenital anomalies or anomalies that limit feeding volumes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -14 to 0, day 1 to 18

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help infants of diabetic mothers who have trouble learning to feed by using an antioxidant to reduce brain stress. This prepares them for a nerve stimulation technique that helps with feeding. The goal is to improve their ability to feed orally and avoid the need for a feeding tube.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant has been diagnosed with cardiomyopathy.

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I have birth defects that affect my ability to eat properly.

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My baby was born before 39 weeks of pregnancy.

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My infant needs help with breathing or is not stable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -14 to 0, day 1 to 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day -14 to 0, day 1 to 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -14 to 0, day 1 to 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Daily Oral Feeding Volumes : Difference in Mean Increase

Secondary study objectives

Metabolite Concentrations in Basal Ganglia

Other study objectives

Diffusion Kurtosis Imaging (DKI)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

N acetyl cysteine + vagus nerve stimulation

2021

Completed Early Phase 1

~10

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Feeding Disorders often involve the use of antioxidants like N-acetylcysteine (NAC), ascorbic acid, and omega-3 fatty acids. These treatments work by reducing oxidative stress in the central nervous system (CNS), which is crucial because oxidative stress can impair brain function and neuroplasticity. NAC, for example, helps to regulate the expression of genes such as brain-derived neurotrophic factor (BDNF), which is essential for motor learning and synaptic plasticity. By mitigating oxidative damage and enhancing gene expression, these treatments can improve feeding behaviors and overall brain health in patients with Feeding Disorders.

The effect of pyrithioxine and pyridoxine on individual behavior, social interactions, and learning in rats malnourished in early postnatal life.Mercaptoacetate-induced feeding is impaired by central nucleus of the amygdala lesions.Ameliorative Role of Cerium Oxide Nanoparticles Against Fipronil Impact on Brain Function, Oxidative Stress, and Apoptotic Cascades in Albino Rats.