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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT02071160
Eligibility Criteria:
Inclusion Criteria:
* Inborn infants at term gestation (38-42 weeks)
* Apgar scores ≤ 3 at 5 minutes and/or delayed first breath (\>5 minutes after birth)
* Profound metabolic or mixed acidosis with serum bicarbonate levels of \<12 mmol/L in initial blood gas analyses
* Evidence of moderate or moderate to severe encephalopathy, such as lethargy, seizures, abnormal reflexes, or hypotonia, in the immediate neonatal period
Exclusion Criteria:
* Twin gestation
* Maternal neuro-endocrinal disturbances including diabetes mellitus
* Chorioamnionitis or congenital infections
* Low birth weight less than 2.5 kg
* Congenital malformations of the central nervous system or gastrointestinal anomalies
* Chromosomal abnormalities
* After 6 hours of birth.
* Patients in extremis such as: (1) hypoxemia requiring supplemental oxygen 100% FiO2, (2) life threatening coagulopathy, or (3) deep coma.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
6 Hours
Study:
NCT02071160
Study Brief:
Protocol Section:
NCT02071160