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.
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