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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT02499393
Eligibility Criteria:
Inclusion Criteria:
Group A Infants \> 36.0 weeks gestation\* with at least ONE of the following: \* for gestational age also use clinical assessment
* Apgar score of less than or equal to ≤5 at 10 (ten) minutes after birth
* continued need for resuscitation, including endotracheal or mask ventilation, at 10min after birth
* acidosis defined as either umbilical cord pH or any arterial, venous or capillary pH within 60 min of birth less than (\<) pH 7.00
* base deficit greater than or equal to (≥) 16 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood)
Group B Newborn with moderate or severe encephalopathy with varying states of consciousness: lethargy, stupor, or coma and
One or more of below:
* hypotonia
* abnormal reflexes : oculomotor / pupillary
* suck: weak / absent
* clinical seizures - clinically confirmed
Group C integrated electroencephalogram (aEEG / CFM) (lasting at least 20 minutes), which indicates either a moderate / serious abnormalities in the background activity aEEG (a score of 2 or 3) or convulsions attacks.
Exclusion Criteria:
* major congenital maformation
* extremely poor prognosis : Apgar score 0 @ 15 minutes of life
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
6 Hours
Study:
NCT02499393
Study Brief:
Protocol Section:
NCT02499393