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NCT04602325 · ClinicalTrials.gov registry record
Systemic Biomarkers of Brain Injury From Hyperammonemia
A clinical trial of Hypoxic Ischemic Encephalopathy and Urea Cycle Disorder, sponsored by Children's National Research Institute.
- Recruiting
- Registry status
- 24
- Enrollment target
- 1
- Study location
NCT04602325: Recruiting study of Hypoxic Ischemic Encephalopathy and Urea Cycle Disorder, sponsored by Children's National Research Institute.
NCT04602325 is a study of Hypoxic Ischemic Encephalopathy and Urea Cycle Disorder that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 24 participants, below the 81-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04602325, a study of Hypoxic Ischemic Encephalopathy and Urea Cycle Disorder, is actively recruiting participants, sponsored by Children's National Research Institute.
- RECRUITING
- Registry status
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
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).
Primary Outcome
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
Conditions Studied
Study Locations (1)
District of Columbia
- Children's National Research Institute - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2027-05 |
What NCT04602325 shows while recruiting
NCT04602325 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 81-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (70% lower).
The record links to 6 conditions, with Hypoxic Ischemic Encephalopathy appearing as the primary indexed condition, and to 0 interventions.
NCT04602325 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04602325 about?
NCT04602325 is a clinical study titled "Systemic Biomarkers of Brain Injury From Hyperammonemia". 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 thi...
What is the current status of trial NCT04602325?
This trial is currently recruiting. The enrollment target is 24 participants. The study started on 2020-07-09. Estimated completion is 2027-05.
What conditions does trial NCT04602325 study?
This clinical trial studies the following conditions: Hypoxic Ischemic Encephalopathy, Urea Cycle Disorder, Organic Acidemia, Maple Syrup Urine Disease, Glutaric Acidemia I.
Who is sponsoring clinical trial NCT04602325?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04602325 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04602325's enrollment target sits among peer trials
24 10th of 13 higher than 4 of 13 other Hypoxic Ischemic Encephalopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoxic Ischemic Encephalopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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