Systemic Biomarkers of Brain Injury From Hyperammonemia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-18
SponsorChildren's National Research Institute

About this trial

Ammonia is a waste product of protein and amino acid catabolism and is also a potent neurotoxin. High blood ammonia levels on the brain can manifest as cytotoxic brain edema and vascular compromise leading to intellectual and developmental disabilities. The following aims are proposed:

Aim 1 of this study will be to determine the chronology of biomarkers of brain injury in response to a hyperammonemic (HA) brain insult in patients with an inherited hyperammonemic disorder.

Aim 2 will be to determine if S100B, NSE, and UCHL1 are altered in patients with two other inborn errors of metabolism, Maple Syrup Urine Disease (MSUD) and Glutaric Acidemia (GA1).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

N-acetylglutamate Synthetase Deficiency (NAGS)

Carbamyl Phosphate Synthetase Deficiency (CPSD)

Ornithine Transcarbamylase Deficiency (OTCD)

Argininosuccinate Synthetase Deficiency (ASD)

Disqualifiers

Prior Solid-Organ Transplant

Use of any other investigational drug, biologic, or therapy or any clinical or laboratory abnormality or medical condition that, as determined by the investigator, may interfere with or obscure the biomarker measurements

Trial population

Eligible subjects will be recruited from the patient population at Children's National Hospital in Washington, DC. Study population will consist of those patients with inherited hyperammonemias, acute metablic disorders, fatty acid oxidation disorders, and hypoxic-ischemic encephalopathy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

24 Participants
are grouped into 4 trial groups
Group A: Inherited Hyperammonemias
Group B: Acute Metabolic Disorder + Neurological Sequelae
Group C: Fatty Acid Oxidation Disorders
Group D: Hypoxic-Ischemic Encephalopathy

Trial outcomes

Primary outcomes

1

Biomarker Brain Injury Chronology

Determine the chronology of biomarkers of brain injury (S100B, NSE, and UCHL1) in response to a hyperammonemic (HA) brain insult in patients with an inherited hyperammonemic disorder

Time frame
2 Years

Secondary outcomes

1

Brain Injury Protein Alterations

Determine if S100B, NSE, and UCHL1 are altered in patients with two other inborn errors of metabolism in which the primary pathology is neurological injury, Maple Syrup Urine Disease (MSUD) and Glutaric Acidemia (GA1)

Time frame
2 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's National Research Institute

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator