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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT01475656
Eligibility Criteria:
Inclusion criteria:
* Gestational age ≥ 35 weeks
* Postnatal age ≤ 30 days
* Birth weight ≥ 2000 grams
* Clinical or electrographic seizures of any etiology requiring treatment with an antiepileptic medication (as per the judgment of the clinician caring for the patient)
* Parental consent obtained
Exclusion criteria:
* Infants with renal insufficiency indicated by serum creatinine \> 2.0 (as part of pre-screening, labs obtained as part of routine care will be reviewed. Infants who have not had a creatinine drawn will have one drawn as part of the study after consent is obtained. If the baby requires levetiracetam emergently before the results of the creatinine are back, the dose will still be given and levels will still be drawn as per the protocol.
* Infants who have previously received levetiracetam
* Parents refuse consent
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Days
Study:
NCT01475656
Study Brief:
Protocol Section:
NCT01475656