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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03640494
Eligibility Criteria:
Inclusion Criteria:
Infants are eligible if:
* Admitted to the intensive care nursery, outborn or inborn, with a clinical diagnosis of HIE; and with the approval of the neonatologist
* A parent or legal guardian provides written informed consent
Exclusion Criteria:
Potentially eligible infants will be excluded if:
• Congenital or chromosomal anomaly that has a profound impact on brain or eye development (e.g. anencephaly, congenital cataract or Peter's anomaly) and infants for whom there has been a clinical decision to limit life support.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
20 Days
Study:
NCT03640494
Study Brief:
Protocol Section:
NCT03640494