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 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT02894866
Eligibility Criteria:
* Inclusion Criteria:
* Newborn infants whose gestational age ≥37 weeks' gestation, weighing over 2500 g ;
* Acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest)
* With an Apgar score ≤ 3 at one minute and ≤5 at five minutes, and/or a potential of hydrogen of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical-cord blood or any blood during the first hour after birth.
* Having moderate-to-severe encephalopathy (indicated by lethargy, stupor, or coma) and either hypotonia, abnormal reflexes (including oculomotor or pupillary abnormalities), an absent or weak suck, or clinical seizures, and/or have abnormal background activity of at least 20 minutes' duration or seizures on amplitude integrated electroencephalography
* Exclusion Criteria:
* A congenital and the hereditary disease, a chromosome abnormalities, and a congenital abnormality.
* During the acute phases of intracranial and (or) fundus hemorrhage. o
* Intracranial infection.
* Pneumothorax.
* Infants who have been received hypothermia.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
7 Days
Study:
NCT02894866
Study Brief:
Protocol Section:
NCT02894866