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Neonatal White Matter Injury Trial (WRAP)

NCT07688746
Conditions
White Matter Injury, Brain Injury, Fetus and Neonate, Neonatal Brain Injury, Periventricular Leukomalacia, Periventricular White Matter Abnormalities
Interventions
Clemastine fumarate
Drug
Lead sponsor
Bridget LaMonica Ostrem, M.D., Ph.D.
Other
Eligibility
3 Weeks to 20 Weeks
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
1
States / cities
San Francisco, California
Conditions
Preterm Less Than 32wks With IVH, WMI/PVL, Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
Interventions
Prospective Clinical and Neurodevelopmental Data Collection
Other
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
31 Weeks to 42 Weeks
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
1
States / cities
Boston, Massachusetts
Conditions
Infant, Premature, Diseases, Brain White Matter Disease Periventricular
Interventions
SPEEDI Intervention
Behavioral
Lead sponsor
Virginia Commonwealth University
Other
Eligibility
Up to 18 Weeks
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
1
States / cities
Richmond, Virginia