Home-based Optimization of Mechanical Ventilation in Children

NCT06055413 | Completed

• 1 other identifier: 2020-3600
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 studies that identify the best ways to monitor a home breathing machine or adjust its settings. Increasingly, healthcare systems are using information collected at home to make more informed decisions about a patient's healthcare treatment, which is called "remote patient monitoring". This study will ask whether using remote patient monitoring can provide more complete information to a child's team of doctors, nurses, and respiratory therapists to help a child's healthcare team and family make more informed decisions about a child's home ventilator care. The investigators are hypothesizing it can safely decrease the level of breathing support children need while also avoiding emergency and hospital care and supporting their growth, development, and participation in daily life.

Conditions

Ventilator Weaning

Keywords

Children with medical complexity; Home mechanical ventilation; Long-term ventilation; Remote patient monitoring; Digital health

Outcome Measures

Primary Outcomes (1)

• Level of ventilator support

  Liters/kg/day

  4 months

Secondary Outcomes (12)

• Cessation of awake positive pressure

  4 months

• Cessation of positive pressure

  4 months

• Ventilator management frequency

  4 months

• Quality of life via participation

  4 months

• Lung symptom control

  4 months

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Patients receiving the intervention.

Other: Remote patient monitoring (RPM) bundle

Interventions

Remote patient monitoring (RPM) bundle OTHER

Patient-families will be given a "remote patient monitoring (RPM) bundle" with tools to measure objective and subjective information about the child at home that are shared with the home ventilator provider team through an electronic dashboard. The tools include a device to measure carbon dioxide, a digital tablet, a digital weight scale, and a digital application that connects to the child's electronic health record. Each child will be assigned an individualized remote monitoring schedule (timing and data type) based on their indication for ventilation and ventilator regimen at enrollment.

Intervention Arm

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Foster C, Noreen P, Grage J, Kwon S, Hird-McCorry LP, Janus A, Davis MM, Goodman D, Laguna T. Predictors for invasive home mechanical ventilation duration in bronchopulmonary dysplasia. Pediatr Pulmonol. 2023 Jul;58(7):2085-2093. doi: 10.1002/ppul.26437. Epub 2023 Apr 28.

  PMID: 37114844 BACKGROUND

• Foster CC, Kwon S, Shah AV, Hodgson CA, Hird-McCorry LP, Janus A, Jedraszko AM, Swanson P, Davis MM, Goodman DM, Laguna TA. At-home end-tidal carbon dioxide measurement in children with invasive home mechanical ventilation. Pediatr Pulmonol. 2022 Nov;57(11):2735-2744. doi: 10.1002/ppul.26092. Epub 2022 Aug 24.

  PMID: 35959530 BACKGROUND

Related Links

• Foster Health Lab
• Primary Investigator

MeSH Terms

Interventions

Remote Patient Monitoring

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Carolyn C Foster, MD, MS

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 26, 2023
• Study Start: September 20, 2023
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)