CHLA Clinical Research Studies
Having volunteers participate in research studies and clinical trials is critical to our research efforts. Thousands of children and families are involved in our patient-centered studies every year. Many of the treatments used today are based on the results of past research studies and clinical trials conducted with our patients. Our scientific and clinical experts take the best ideas from the laboratory -- to the patient -- in the form of promising new treatments.
By searching our study directory, you may identify research that could impact the life of your child or of another child you know. Because the number of available research studies and clinical trials for children nationwide is small, every participant makes a significant contribution.
In addition to enrolling children with certain diseases in order to study treatments and prevention of those diseases, we also need to study healthy children. Ask your child’s doctor about volunteer study options that may be suitable for your child.
Please contact the study staff listed in your search results for more information.
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|Study Details - ID: CHLA-16-00535|
hypoxic-ischemic encephalopathy (HIE)
HIGH DOSE ERYTHROPOIETIN FOR ASPHYXIA AND ENCEPHALOPATHY (HEAL)
|Full Title of Study:|
HIGH DOSE ERYTHROPOIETIN FOR ASPHYXIA AND ENCEPHALOPATHY A randomized, placebo-controlled, double-masked 500 - subject clinical trial of erythropoietin for the treatment of neonatal hypoxic-ischemic encephalopathy (HIE)
|Phase/Type of Study:|
Prospective, randomized, double-masked, placebo-controlled study - Phase III
|Purpose of Research:|
1) To determine if 5 doses of Epo 1000 U/kg (birth weight) intravenous (IV) reduces the rate of death or neurodevelopmental impairment (mild, moderate, or severe) at 24 months of age. 2) To assess safety of Epo. 3) To determine whether Epo decreases the severity of HIE-induced brain injury as evidenced by early MRI and plasma biomarkers of brain injury.
1. Newborns ≥ 36 weeks gestational age 2. Receiving active or passive whole body cooling/hypothermia since < 6 hours of age 3. 2.Perinatal depression. 3. Moderate to severe encephalopathy.
24 month study. Study drug dose #1-5 given days 1-7. Follow up phone calls: Months 4, 8, 12, 18, 24. 24 month can also be a clinic visit.
|Coordinator Contact Name:|
|Clinical Trials .Gov Identifier:NCT02811263|