Status:

NOT_YET_RECRUITING

Palliative Care Needs of Children With Rare Diseases and Their Families

Lead Sponsor:

Children's National Research Institute

Collaborating Sponsors:

Akron Children's Hospital

Stanford University

Conditions:

Trisomy 13 Syndrome

Arthrogryposis Congenita Multiplex With Intestinal Atresia

Eligibility:

All Genders

12-99 years

Phase:

NA

Brief Summary

The palliative care needs of family caregivers of children with rare diseases and their children are largely unmet, including the need for support to prepare for future medical decision making. This t...

Detailed Description

Pediatric patients with rare diseases experience high mortality with 30% not living to see their 5th birthday. Families are likely to be asked to make complex medical decisions for their child. Pediat...

Eligibility Criteria

Inclusion

  • Child inclusion criteria:
  • ≥1.0 years and \<18.0 years at enrollment.
  • Unable to participate in end-of-life care decision-making.
  • Has a rare disease as operationally defined by NIH's Genetic and Rare Diseases Information Center (GARD).
  • Not under a Do Not Resuscitate Order or Allow a Natural Death Order.
  • Not in the Intensive Care Unit.
  • Family caregiver inclusion criteria:
  • \> 18.0 years at enrollment.
  • Child's family caregiver/legal guardian.
  • Not known to be developmentally delayed.
  • Support person inclusion criteria:
  • \> 18.0 years at enrollment.
  • Chosen by family caregiver.
  • Not known to be developmentally delayed.
  • Exclusion Criteria:
  • Family caregiver or support person is actively homicidal, suicidal, or psychotic at the time of enrollment.

Exclusion

    Key Trial Info

    Start Date :

    February 2 2026

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 31 2030

    Estimated Enrollment :

    480 Patients enrolled

    Trial Details

    Trial ID

    NCT06938542

    Start Date

    February 2 2026

    End Date

    January 31 2030

    Last Update

    April 22 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Children's National Hospital

    Washington D.C., District of Columbia, United States, 20010