Neonatal White Matter Injury Trial (WRAP)

Recruiting Phase 1 Interventional Study
White Matter Injury Brain Injury, Fetus and Neonate Neonatal Brain Injury Periventricular Leukomalacia Periventricular White Matter Abnormalities
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
3 Weeks – 20 Weeks
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Bridget LaMonica Ostrem, M.D., Ph.D. · Other
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About This Trial
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 m…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Born at ≤32 weeks gestational age based on prenatal ultrasound or last menstrual period (LMP). 2. Current age of between 35-41 weeks PMA. 3. Imaging evidence of white matter injury on any scan as defined by either brain MRI or cUS criteria: * Brain MRI with Grade Ib WMI o…
Contacts

Audrey Hernando, BS

415-502-2425

audrey.hernando@ucsf.edu

CONTACT

Lena Odell, BA

elizabeth.odell@ucsf.edu

CONTACT