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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT01506258
Eligibility Criteria:
Inclusion Criteria:
* Apgar \< 5 at 5 minutes
* Mixed or metabolic acidosis with a pH \<7.0 from umbilical cord blood sample
* Neurological manifestations compatible with Hypoxic-Ischemic Encephalopathy
* Any degree of organic/systemic affectation (cardiovascular, gastrointestinal, hematologic and/or respiratory)
Exclusion Criteria:
* Neurodegenerative, autoimmune or genetic disease
* Active infection at birth
* Informed Consent not signed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
37 Weeks
Maximum Age:
42 Weeks
Study:
NCT01506258
Study Brief:
Protocol Section:
NCT01506258