Status:
COMPLETED
FACE for Children With Rare Diseases
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
Respecting Choices
National Institutes of Health (NIH)
Conditions:
Rare Diseases
Eligibility:
All Genders
1-99 years
Phase:
NA
Brief Summary
Children with ultra-rare or complex rare diseases are routinely excluded from research studies because of their conditions, creating a health disparity. However, new statistical techniques make it pos...
Detailed Description
A rare disease is a condition affecting fewer than 200,000 persons. Pediatric patients with rare diseases experience high mortality with 30% not living to see their 5th birthday. Families are likely t...
Eligibility Criteria
Inclusion
- Child inclusion criteria are
- ≥1.0 years and \<18.0 years at enrollment;e
- unable to participate in end-of-life care decision-making;
- have a rare disease as operationally defined (See Human Subjects);
- not under a Do Not Resuscitate Order or Allow a Natural Death Order; and
- not in the Intensive Care Unit.
- Family caregiver inclusion criteria are:
- ≥ 18.0 years at enrollment;
- legal guardian of child and child's caregiver;
- can speak and understand English; and
- not known to be developmentally delayed.
Exclusion
- (1) Family caregiver is actively homicidal, suicidal, or psychotic at the time of enrollment.
Key Trial Info
Start Date :
July 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04855734
Start Date
July 6 2021
End Date
June 1 2024
Last Update
May 4 2025
Active Locations (1)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010