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Status:

COMPLETED

Home-based Optimization of Mechanical Ventilation in Children

Lead Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Conditions:

Ventilator Weaning

Eligibility:

All Genders

Up to 17 years

Phase:

NA

Brief Summary

Some children who are born very early or have other congenital conditions may develop severe, long-term lung problems that make them need to use a breathing machine to live at home. There are no studi...

Detailed Description

This is a single-arm, non-randomized, open-label trial using remote patient monitoring for chronic management of invasive home mechanical ventilation in children. The investigators hypothesize that in...

Eligibility Criteria

Inclusion

  • Family-Patient Inclusion criteria
  • The patient uses invasive mechanical ventilation at home during any portion of the day at time of enrollment.
  • The patient is 0 to 17 years old.
  • The patient has at least one family caregiver (parent or other self-identified legal guardian) trained on home ventilator use who is willing to participate.
  • The primary parental participant reads and speaks either English or Spanish.
  • Exclusion criteria
  • The patient has progressive neuromuscular or other condition for which decreasing support during the day is not anticipated.
  • The patient is already off of ventilation during the day while awake.
  • The patient will turn 18 during participation.
  • The patient has planned a transition of care to another institution or move during the planned study period after enrollment.
  • The patient is in active hospice or similar end-of-life care at time of study enrollment.
  • The patient is living in long-term institution, transitional facility, or not within a stable home setting during the study period.

Exclusion

    Key Trial Info

    Start Date :

    September 20 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 24 2025

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT06055413

    Start Date

    September 20 2023

    End Date

    October 24 2025

    Last Update

    October 31 2025

    Active Locations (1)

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    1

    Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, United States, 60611