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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07401433
Eligibility Criteria:
Inclusion Criteria:
* Neonates (0-28 days old) with clinically diagnosed seizures.
* Both term and preterm neonates.
* Admitted to the neonatal intensive care unit (NICU) or pediatric ward.
* Written informed consent obtained from parents or legal guardians.
Exclusion Criteria:
* Neonates with major congenital anomalies or genetic syndromes.
* Neonates with severe renal or hepatic impairment.
* Neonates with metabolic disorders requiring specific treatment (e.g., hypoglycemia, hypocalcemia) unless seizures persist after correction.
* Neonates already receiving anticonvulsant therapy prior to admission.
* Neonates with confirmed meningitis or central nervous system infections requiring specific management (unless seizures persist after appropriate treatment).
* Neonates with life-threatening conditions where study treatment cannot be safely administered.
* Parents or legal guardians refusing consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
28 Days
Study:
NCT07401433
Study Brief:
Protocol Section:
NCT07401433