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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT02529202
Eligibility Criteria:
Inclusion Criteria:
1. Newborns 36 weeks gestation or older with moderate to severe hypoxic-ischemic encephalopathy identified and treated with therapeutic hypothermia in the Seattle Children's Hospital neonatal intensive care unit.
2. Cooled infants who are initially intubated and mechanically ventilated.
3. Infants anticipated to require 72 hrs of continuous sedation and/or treatment to prevent shivering.
4. Subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
Exclusion Criteria:
1. Known chromosomal anomalies.
2. Newborns without central lines (e.g., lines not needed or unable to be successfully placed) or without a peripheral arterial line.
3. Patients with known cyanotic congenital heart defects
4. Patients who are participating in another clinical trial.
5. Patients who received DEX prior to enrollment in the study
6. At the discretion of the Investigator, subjects in whom the risk of Dexmedetomidine treatment is expected to exceed its benefits.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
1 Day
Study:
NCT02529202
Study Brief:
Protocol Section:
NCT02529202