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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT04086992
Eligibility Criteria:
Inclusion Criteria:
* Patients admitted to CHCO, Anschutz and Colorado Springs hospitals, under the age of 30 months with a primary diagnosis of Infantile Spasms and started on first-time ACTH and their primary caregiver (parent/guardian).
Exclusion Criteria:
* Infants with recurrent Infantile Spasms and retreatment with ACTH and their primary caregiver (parent/guardian).
* Infants with existing home health nursing services and their primary caregiver (parent/guardian).
* Infants with prolonged inpatient admissions beyond 7 days after initiation on ACTH and their primary caregiver (parent/guardian).
* Infants whose caregivers do not read, write, and/or speak English with sufficient proficiency to provide informed consent and their primary caregiver (parent/guardian).
* Neonates less than 31 days old and their primary caregiver (parent/guardian).
* Infants that have been hospitalized since birth and their primary caregiver (parent/guardian).
* Infants that are wards of the state and their primary caregiver (guardian).
* Infants that reside in a geographic location with no major network cell service and their primary caregiver (parent/guardian).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
31 Days
Maximum Age:
30 Months
Study:
NCT04086992
Study Brief:
Protocol Section:
NCT04086992