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 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT06098833
Eligibility Criteria:
Inclusion Criteria:
* Male and female neonates meeting the criteria for induced hypothermia:
* Gestational age ≥36weeks and birth weight ≥1800g;
* Evidence of fetal distress, i.e., history of an acute perinatal event, cord pH ≤7.0 or base deficit
* 16 mEq/L;
* Evidence of neonatal distress, such as an Apgar score ≤5 at 10 minutes, postnatal blood gas pH obtained within the first hour of life ≤ 7.0 or base deficit ≤ - 16 mEq/L, or a continued need for ventilation initiated at birth and continued for at least 10 minutes;
* Evidence of moderate to severe neonatal encephalopathy by an abnormal neurological exam and/or an amplitude-integrated electroencephalogram (aEEG). They will receive whole-body cooling to an esophageal temperature of 33.5°C, initiated within the first 6 hours of life, continued for 72 hours, and then they will be slowly rewarmed using standard protocol.
* Evidence of brain injury on a brain magnetic resonance imaging (MRI) performed on day 2 of life.
Exclusion Criteria:
* Neonates with complex congenital heart disease
* Neonates with cerebral malformations
* Neonates with genetic syndrome
* Neonates with intraventricular and/or intraparenchymal hemorrhage on MRI performed on day 2 of life
* Moribund infants not expected to survive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Minutes
Maximum Age:
48 Hours
Study:
NCT06098833
Study Brief:
Protocol Section:
NCT06098833