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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT07292220
Eligibility Criteria:
Inclusion Criteria:
1. Newborns with a gestational age ≥36 weeks (term)
2. Diagnosis of hypoxic ischemic encephalopathy (HIE) based on clinical and/or laboratory findings
3. Diagnosis of stage I, stage II, or stage III HIE according to the Sarnat staging system
4. Therapeutic hypothermia (TH) treatment initiated within the first 6 hours after birth
5. Written consent obtained from the legal parent(s) for participation in the study
Exclusion Criteria:
1. Major congenital malformation or genetic syndrome (e.g., Trisomy 21, congenital heart disease)
2. Newborns with suspected sepsis, metabolic disease, or other systemic disease
3. Premature infants with a gestational age \<36 weeks
4. Therapeutic hypothermia treatment not started on time or inadequately administered
5. Medical conditions preventing blood sampling (e.g., severe coagulopathy, circulatory instability)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
28 Days
Study:
NCT07292220
Study Brief:
Protocol Section:
NCT07292220