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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03602118
Eligibility Criteria:
Inclusion Criteria:
1. Parental informed consent
2. Infants born at ≥ 35 + 0/7 weeks gestational age AND age 0-28 days after birth
3. Has evidence of an electrographic seizure lasting at least 10 seconds
4. Undergoing continuous electroencephalogram, (EEG), monitoring, including infants with hypoxic-ischemic encephalopathy concurrently treated with hypothermic cooling
Exclusion Criteria:
1. If the seizures are solely due to a transient abnormality, easily correctable, and unlikely to recur (for example, transient electrolyte abnormalities)
2. If the infant has been diagnosed with or there is a strong suspicion of an inborn error of metabolism, significant brain malformation, or microcephaly (\< 3rd percentile)
3. If the infant has been diagnosed with an intrauterine viral infection
4. If the infant is not expected to survive to discharge
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
28 Days
Study:
NCT03602118
Study Brief:
Protocol Section:
NCT03602118