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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT04855734
Eligibility Criteria:
Inclusion Criteria:
Child inclusion criteria are
1. ≥1.0 years and \<18.0 years at enrollment;e
2. unable to participate in end-of-life care decision-making;
3. have a rare disease as operationally defined (See Human Subjects);
4. not under a Do Not Resuscitate Order or Allow a Natural Death Order; and
5. not in the Intensive Care Unit.
Family caregiver inclusion criteria are:
1. ≥ 18.0 years at enrollment;
2. legal guardian of child and child's caregiver;
3. can speak and understand English; and
4. not known to be developmentally delayed.
Exclusion Criteria:
(1) Family caregiver is actively homicidal, suicidal, or psychotic at the time of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
99 Years
Study:
NCT04855734
Study Brief:
Protocol Section:
NCT04855734