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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT01089504
Eligibility Criteria:
Inclusion Criteria:
* Birth at \> 34 weeks' gestation
* Neonatal seizures (clinical, electrographic or both), with onset in the first 120 hours after birth and resolution within 7 days of onset
* Parental informed consent
Exclusion Criteria:
* Birth at \< 34 weeks' gestation
* If the attending neonatologist attributes the seizures solely to a transient abnormality, easily correctable and unlikely to recur (eg, transient electrolyte abnormalities). If the attending neonatologist cannot be contacted, the site PI will be asked to review the available information and judge whether the infant is eligible.
* If the infant has been diagnosed with or there is a strong suspicion of an inborn error of metabolism, significant brain malformation, microcephaly (\< 3 %ile), or a chromosomal abnormality which, in the absence of seizures, is known to be independently associated with an increased likelihood of cognitive impairment
* If the infant has been diagnosed with an intrauterine viral infection
* If the infant is not expected to survive to discharge
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Days
Maximum Age:
2 Weeks
Study:
NCT01089504
Study Brief:
Protocol Section:
NCT01089504