Clinical trial Recruiting at 6 sites Interventional Ages 1 Month to 18

Using a decision support tool to improve ventilation in children with ARDS

Official title: A Computerized Decision Support Tool for Ventilator Management in Pediatric Acute Respiratory Distress Syndrome Pilot Study

Run by Children's Hospital Los Angeles · NCT04068012 · Data updated 2026-11-12

This study is trying out a new tool to help doctors manage breathing machines better for kids with serious lung problems to see if it can improve their recovery.

Quick facts

Study typeInterventional
Ages1 Month to 18 Years
SexAll
Enrollment180 (estimated)
SponsorChildren's Hospital Los Angeles
Academic / other
Locations8 sites (Chicago, Illinois and 7 other locations)
StatusRecruiting
StartedDecember 1, 2020
Main results expectedJuly 2027
Study endsJuly 1, 2027
Registry record updatedApril 14, 2026
Trial IDNCT04068012 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include children over 1 month and under 18 years of age who are on mechanical ventilation for PARDS and meet specific oxygenation criteria.

Probably not a fit

Patients with conditions that prevent conventional weaning methods or those with severe respiratory complications may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to implement a Clinical Decision Support (CDS) tool to standardize ventilator management for infants and children suffering from Pediatric Acute Respiratory Distress Syndrome (PARDS). The CDS tool, developed at Children's Hospital Los Angeles, will be deployed across multiple Pediatric Intensive Care Units (PICUs) to enhance adherence to evidence-based practices in mechanical ventilation. The study will assess the feasibility, acceptability, and compliance with the CDS recommendations, targeting improvements in patient outcomes such as reduced time on mechanical ventilation and minimized ventilator-induced injuries. Data will be captured automatically to ensure timely and relevant information is provided to clinicians.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and reduced complications for children with PARDS requiring mechanical ventilation.

How similar studies have gone: Previous studies have shown success in adult populations using similar decision support tools, indicating potential for positive outcomes in pediatric settings as well.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Children \> 1 month of age and \>44 weeks gestation and ≤ 18 years of age AND
* Supported on mechanical ventilation with pulmonary parenchymal disease (i.e. Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5) or Oxygenation Index (OI) ≥ 4 AND
* Who are within 72 hours of initiation of invasive mechanical ventilation AND
* Who are anticipated to require \>72 hours mechanical ventilation.

Exclusion Criteria:

* Conditions on enrollment that preclude conventional methods of weaning (i.e., status asthmaticus, severe lower airway obstruction, bronchiolitis, critical airway, Extra Corporeal Life Support (ECLS), intubation for Upper Airway Obstruction, Do Not Resuscitate orders, severe chronic respiratory failure, spinal cord injury above lumbar region, cyanotic heart disease (unrepaired or palliated)) OR
* Conditions precluding the use of permissive hypercapnia or hypoxemia (i.e. intracranial hypertension, severe pulmonary hypertension)
* Primary Attending physician refuses to enroll the patient

Where it's running

  • Ann & Robert H. Lurie Children's Hospital of Chicago
    Chicago, Illinois, United States
    Recruiting
  • Riley Hospital for Children
    Indianapolis, Indiana, United States
    Recruiting
  • Penn State University
    Hershey, Pennsylvania, United States
    Recruiting
  • University of Wisconsin-Madison
    Madison, Wisconsin, United States
    Recruiting
  • Children's Hospital of Wisconsin
    Milwaukee, Wisconsin, United States
    Recruiting
  • CHU Sainte-Justine
    Montreal, Quebec, Canada
    Recruiting
Show 2 more locations
  • University of Utah
    Salt Lake City, Utah, United States
    Not yet recruiting
  • Ospedale Pediatrico Bambino Gesu
    Roma, Italy
    Not yet recruiting

Study contacts

  • Principal investigator: Christopher J Newth, MD — Children's Hospital Los Angeles
  • Study coordinator: Christopher J Newth, MD
  • Email: cnewth@chla.usc.edu
  • Phone: 3233612557

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.