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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT03572257
Eligibility Criteria:
Inclusion Criteria:
* Age 0 - 21 years old
* PICU admission
* Positive CAPD scoring
* For developmentally normal children a CAPD score of ≥ 9
* For developmentally delayed a CAPD score of ≥ 9 and a Richmond Agitation Sedation Scale (RASS) fluctuation of at least 2 points in the last 24 hours
Exclusion Criteria:
* Patients under neuromuscular blockade and/or therapeutic hypothermia.
* Patients undergoing treatment of alcohol withdrawal.
* Patients unable to tolerate enteral medications
* Patients on antipsychotics
* Patients with a history of:
* hepatic encephalopathy, hepatitis
* elevated liver enzymes defined ALT or AST above normal range for age since hospitalization
* baseline QTc prolongation (defined as greater than 97th percentile for age or greater than 20% increase from baseline or previous QTc)
* major depressive disorder or bipolar disorder, and movement disorder.
* Patients who are pregnant
* Non-English and non-Spanish speaking subjects and/or parent/guardian
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT03572257
Study Brief:
Protocol Section:
NCT03572257