The researchers are investigating a new treatment for white matter injury, which is a common type of brain injury in premature babies. The drug, clemastine, is experimental. This means that the drug is not approved by the Food and Drug Administration (FDA) for the treatment of white matter injury. The main purpose of this study is to learn whether clemastine is safe to give to infants with white matter injury. The researchers also want to understand how much clemastine gets into an infant's body when the medication is taken by mouth, and how long it stays in the body.
Born at ≤32 weeks gestational age based on prenatal ultrasound or last menstrual period (LMP).
Current age of between 35-41 weeks PMA.
Brain MRI with Grade Ib WMI or higher based on the Martinez-Biarge et al 2016 criteria.
cUS with Grade 3 or higher white matter abnormalities based on Miller et al 2003 criteria.
Known or suspected metabolic or chromosomal disorder or major congenital anomalies
Major intracranial hemorrhage within the last 1 week or intracranial hemorrhage of any age that is not controlled or continuing to cause significant mass effect or midline shift.
History of cardiac arrhythmia or current ongoing tachycardia with baseline heart rate >10% age expected norms.
Hypotension requiring ongoing vasopressor or inotropic support.
Bridget LaMonica Ostrem, M.D., Ph.D.
Lead sponsor
University of California, San Francisco
Sponsor institution
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator