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

Dead Space and Inhaled Nitric Oxide in Pediatric Acute Respiratory Distress Syndrome

This study is testing if a specific marker can help predict the risk of death in children with acute respiratory distress syndrome and see how well inhaled nitric oxide treatment works for them.

Quick facts

• Study type: Observational
• Enrollment: 1260 (estimated)
• Ages: 0 Years to 21 Years
• Sex: All
• Sponsor: Children's Hospital Los Angeles (other)
• Locations: 10 sites (Los Angeles, California and 9 other locations)
• Trial ID: NCT06690801 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include children aged over 37 weeks corrected gestational age to 21 years who are mechanically ventilated and meet the criteria for moderate to severe pediatric ARDS.

Not a fit: Patients receiving non-conventional invasive mechanical ventilation or those not meeting the ARDS criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve risk assessment and treatment strategies for children with acute respiratory distress syndrome.

How similar studies have performed: While the approach of using AVDSf as a marker in ARDS is innovative, similar studies have shown promise in understanding treatment effects in respiratory conditions.

Eligibility criteria

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 this trial is running

Los Angeles, California and 9 other locations

• 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)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (NOT_YET_RECRUITING)
• Texas Children's Hospital Baylor College of Medicine — Houston, Texas, United States (NOT_YET_RECRUITING)
• American Family Children's Hospital / University of Wisconsin-Madison — Madison, Wisconsin, United States (NOT_YET_RECRUITING)
• Children's Hospital of Wisconsin / Medical College of Wisconsin — Milwaukee, Wisconsin, United States (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Anoopindar M Bhalla, MD — Children's Hospital Los Angeles
• Study coordinator: Jeni Kwok

Conditions: Acute Respiratory Distress Syndrome, Pediatrics, Mechanical Ventilation, Inhaled Nitric Oxide