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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT02551003
Eligibility Criteria:
Inclusion Criteria:
1. Gestational age ≥ 34 weeks
2. Birth weight ≥ 1800 grams
3. 10-minute Apgar score ≤5 or continued need for ventilation or severe acidosis, defined as pH \<7.0
4. Moderate to severe encephalopathy (Sarnat II to III)
5. A moderately or severely abnormal background aEEG voltage, or seizures identified by aEEG, if monitored
6. Up to 24 hours of age
7. Autologous umbilical cord blood available to infuse 3 doses within 72 hours after birth
8. Parental informed consent
Exclusion Criteria:
1. Known major congenital anomalies, such as chromosomal anomalies, heart diseases
2. Major intracranial hemorrhage identified by brain ultrasonography or computed tomography
3. Severe intrauterine growth restriction (weight \<1800g)
4. Severe infectious disease, such as sepsis
5. Inability to enroll by 24 hours of age
6. Volume of collected cord blood \<40 ml
7. Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist
8. Parents refuse consent
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
24 Hours
Study:
NCT02551003
Study Brief:
Protocol Section:
NCT02551003