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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT04242602
Eligibility Criteria:
Inclusion Criteria:
* Ages 28 days-18 years admitted to the PICU at Children's Medical Center Dallas
* Acute presentation (\< 24 hour) onset of neurologic injury
* Acute neurologic injury can be due to any of the following mechanisms:
* Severe accidental or abusive traumatic brain injury
* Severe encephalopathy secondary to cardiac arrest
* Spontaneous intracranial hemorrhage
* Status epilepticus
* Stroke
* Presence of or pending placement of invasive indwelling arterial line for stand medical care
* Any patient with an ICP monitor placed as standard of care
Exclusion Criteria:
* Patients without an arterial line placed as standard of care
* Patients unable to cooperate with wearing a TCD headpiece device
* Expected death within 24-48 hours
* Inability to place NIRS probes or insonate TCD signal due to massive facial or cranial injury
* Receiving an inhalational anesthetic agent
* Hemoglobinopathy, myoglobinemia or and hyperbilirubinemia (due to inaccurate NIRS readings)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
28 Days
Maximum Age:
18 Years
Study:
NCT04242602
Study Brief:
Protocol Section:
NCT04242602