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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT01862250
Eligibility Criteria:
Inclusion Criteria:
* Infants ≥35 0/7 weeks gestation with the diagnosis of HIE who are being treated with therapeutic hypothermia, who have indwelling arterial lines
* Informed parental consent
Exclusion Criteria:
* Infants who are considered moribund and the clinical team is considering withdrawal of support
* Infants who need \> 20 µg/kg/min of dopamine or the addition of epinephrine or dobutamine to maintain a mean arterial pressure (MAP) ≥ 45 mmHg, or milrinone for cardiovascular support
* Baseline heart rate (HR) \<80 bpm during hypothermia
* Infants suspected of major chromosomal anomalies, except trisomy 21
* Infants with major cardiovascular anomalies
* Infants with severe persistent pulmonary hypertension of the newborn who are enrolled and who then need Extracorporal Membrane Oxygenation (ECMO) will be withdrawn from the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Weeks
Maximum Age:
42 Weeks
Study:
NCT01862250
Study Brief:
Protocol Section:
NCT01862250