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A Phase IIb Dose Escalation Study of Levetiracetam for the Treatment of Neonatal Seizures
The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dos…
Neonatal Neurological Observation With Video AI
NeoNOVA is a multi-site, prospective, single-arm, silent observational study to determine: among (Population) infants admitted to newborn services during their…
Visual Function as a Novel Outcome Measure Following Neonatal Hypoxic Ischemic Encephalopathy
The purpose of this research study is to gather more information on how eye injury is related to a baby's future development and see if eye function and brain …
Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants: A Randomized, Controlled Trial
Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to…
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 cytotox…
Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)
This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in th…
A Phase 2, Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia With Long-Term Follow-Up
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 6…
Transcutaneous Stimulation and Mobility Device Use for Individuals With Neurologic Conditions
This research study will combine non-invasive spinal stimulation with mobility devices to examine the acute impact of the individual and combined effects of th…