Investigating Dead Space and Inhaled Nitric Oxide in Children with Acute Respiratory Distress Syndrome

Is this trial a fit for you?

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

What this trial studies

This observational study aims to evaluate the association between a specific marker of dead space (AVDSf) and mortality risk in pediatric patients with acute respiratory distress syndrome (ARDS). It will also explore whether AVDSf can indicate variability in the treatment effects of inhaled nitric oxide (iNO) therapy. The study will involve 1260 mechanically ventilated children, with a subgroup of 450 children providing longitudinal blood samples to assess microvascular dysfunction. The goal is to enhance risk stratification and treatment personalization for children suffering from ARDS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>37 weeks corrected gestational age to 21 years, including adults lacking the capacity to consent.
* Within 72 hours of the start of invasive mechanical ventilation and meet the criteria for pediatric ARDS (new infiltrate on chest imaging and a known ARDS risk factor within 7 days of the onset of hypoxemia) and either meet criteria for moderate or severe pediatric ARDS between 4-72 hours of IMV (OI ≥ 8 or OSI ≥ 7.5) OR have an OI ≥ 20 or an OSI ≥ 14 x 15 minutes between 0-4 hours of IMV.
* Subgroup of children eligible for longituduinal Blood Collection: Children with severe PARDS (OI ≥ 16 or an OSI ≥ 12 between 4-72 hours of IMV) or those with an OI ≥ 20 or an OSI ≥ 14 for 15 minutes between 0-4 hours of IMV will be eligible for collection of longitudinal plasma samples.

Exclusion Criteria:

* Non-conventional invasive mechanical ventilation (i.e. High Frequency Oscillatory Ventilation, Airway Pressure Release Ventilation) at the time of ICU admission
* ECMO or iNO (or other inhaled pulmonary vasodilator therapy) at the time of ICU admission
* Significant lower airways obstruction (examination of ventilator and capnography waveforms by site study or medical team)
* Air leak \>20% (endotracheal tube, tracheostomy tube, or thoracostomy tube)
* Home Invasive Mechanical Ventilation
* Cyanotic Congenital Heart Disease
* Previous enrollment in the DiNO study
* Do not resuscitate order at the time of pediatric ARDS diagnosis.
* Blood gas not obtained prior to initiation of ECMO, iNO, or non-conventional ventilation.

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• Children's Hospital Colorado
  Denver, Colorado, United States Not yet recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Not yet recruiting
• University of Michigan / CS Mott Children's Hospital
  Ann Arbor, Michigan, United States Active not recruiting
• University of Nebraska Medical Center / Children's Hospital and Medical Center
  Omaha, Nebraska, United States Not yet recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Not yet recruiting

Study contacts

• Principal investigator: Anoopindar M Bhalla, MD — Children's Hospital Los Angeles
• Study coordinator: Jeni Kwok
• Email: dinostudy@chla.usc.edu
• Phone: 3233617939

Similar studies

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

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• Umbilical‑cord mesenchymal stem cell and secretome therapy for severe ARDS

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• Human umbilical cord mesenchymal stem cell injection for moderate to severe ARDS

  This will test whether a single injection of human umbilical cord mesenchymal stem cells can help adults with moderate to severe ARDS that hasn't improved after standard treatment.

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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.