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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT01765218
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible for cooling the baby must meet all three of the following sets of criteria
1. Be near term (typically ≥34wks gestation) and be aged \< 6h old
2. Have signs of early perinatal depression (EITHER 10 minute Apgar score \< 5, OR pH \< 7.00 within 60mins of age, OR Base Excess \< -12 within 60mins of age, OR need respiratory support at 10min of age due to respiratory depression)
3. Have signs of moderate or severe encephalopathy based on either clinical examination or on amplitude integrated aEEG assessment
Exclusion Criteria:
1. Known congenital myopathy
2. Known congenital neuropathy
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Hours
Study:
NCT01765218
Study Brief:
Protocol Section:
NCT01765218