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:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT06985303
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of periventricular leukomalacia (PVL) confirmed by MRI
* Clinically stable at time of intervention
* Parental or legal guardian consent if participant is a minor
Exclusion Criteria:
* Severe congenital brain malformations unrelated to PVL
* Active CNS infection or systemic inflammatory disease
* History of severe intraventricular hemorrhage (Grade III/IV)
* Known allergy or history of a significant hypersensitivity reaction to the investigational product or any of its components.
* Participation in another interventional study within the past 30 days
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06985303
Study Brief:
Protocol Section:
NCT06985303