Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT03171818
Eligibility Criteria:
Inclusion Criteria:
* Newborns ≥ 36+0 weeks of gestation, both male and female
* MRI confirmed diagnosis of acute PAIS, in the MCA region with involvement of the cortical spinal tract (e.g. Posterior Limb of Internal Capsule \[PLIC\] or peduncles) within one week after birth
* Written informed consent from custodial parent(s)
Exclusion Criteria:
* Moderate -severe Hypoxic-Ischemic Encephalopathy (HIE) with or without hypothermia therapy
* Any proven or suspected major congenital anomaly, chromosomal disorder, metabolic disorder;
* Presence of a serious infection of the central nervous system;
* No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician.
* Infant for whom withdrawal of supportive care is being considered.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
7 Days
Study:
NCT03171818
Study Brief:
Protocol Section:
NCT03171818