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 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT02256618
Eligibility Criteria:
Inclusion Criteria:
Infants are eligible if they meet all the following inclusion criteria except 4.
1. ≥36 weeks gestation
2. Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH \<7.0 or base deficit ≥16 mmol/L in a sample of umbilical cord blood or any blood during the first hour after birth
3. Moderate to severe encephalopathy (Sarnat II to III)
4. A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored
5. Up to 24 hours of age
6. Autologous umbilical cord blood available to infuse within 3 days after birth
7. A person with parental authority must have consented for the study.
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 growth restriction, with birth-weight less than 1800 g
4. Severe infectious disease, such as sepsis
5. Hyperkalemia
6. Outborn infants (Infants born at hospitals other than the study sites)
7. Volume of collected cord blood \<40 ml
8. Infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
24 Hours
Study:
NCT02256618
Study Brief:
Protocol Section:
NCT02256618