RECRUITING

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

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Conditions

Acute Respiratory Distress SyndromePediatricsMechanical VentilationInhaled Nitric Oxide

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this observational study is to determine whether a marker of dead space (the end-tidal to alveolar dead space fraction \[AVDSf\]) is more strongly associated with mortality risk than markers of oxygenation abnormality (oxygenation index) and to determine whether dead space (AVDSf) is an important marker of heterogeneity in the inhaled nitric oxide (iNO) treatment effect for children with acute respiratory distress syndrome (ARDS). The study aims are: 1. To validate AVDSf for risk stratification of mortality in pediatric ARDS 2. To determine if there is heterogeneity in treatment effect for iNO defined by AVDSf 3. To detect the association between AVDSf and microvascular dysfunction trajectory and whether iNO therapy modifies this association This is a prospective, multicenter observational study of 1260 mechanically ventilated children with moderate to severe ARDS. In a subgroup of 450 children with severe ARDS, longitudinal blood samples will be obtained to measure plasma protein markers.

Official Title

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

Quick Facts

Study Start:2024-10-03
Study Completion:2029-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06690801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>37 weeks corrected gestational age to 21 years, including adults lacking the capacity to consent.
  2. * 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.
  3. * 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.
  1. * Non-conventional invasive mechanical ventilation (i.e. High Frequency Oscillatory Ventilation, Airway Pressure Release Ventilation) at the time of ICU admission
  2. * ECMO or iNO (or other inhaled pulmonary vasodilator therapy) at the time of ICU admission
  3. * Significant lower airways obstruction (examination of ventilator and capnography waveforms by site study or medical team)
  4. * Air leak \>20% (endotracheal tube, tracheostomy tube, or thoracostomy tube)
  5. * Home Invasive Mechanical Ventilation
  6. * Cyanotic Congenital Heart Disease
  7. * Previous enrollment in the DiNO study
  8. * Do not resuscitate order at the time of pediatric ARDS diagnosis.
  9. * Blood gas not obtained prior to initiation of ECMO, iNO, or non-conventional ventilation.

Contacts and Locations

Study Contact

Jeni Kwok
CONTACT
3233617939
dinostudy@chla.usc.edu
Anoopindar Bhalla, MD
CONTACT
3233617939
abhalla@chla.usc.edu

Principal Investigator

Anoopindar M Bhalla, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Children's Hospital Colorado
Denver, Colorado, 80204
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan / CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
University of Nebraska Medical Center / Children's Hospital and Medical Center
Omaha, Nebraska, 68198
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Texas Children's Hospital Baylor College of Medicine
Houston, Texas, 77030
United States
American Family Children's Hospital / University of Wisconsin-Madison
Madison, Wisconsin, 53792
United States
Children's Hospital of Wisconsin / Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Children's Hospital Los Angeles

  • Anoopindar M Bhalla, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-03
Study Completion Date2029-02-01

Study Record Updates

Study Start Date2024-10-03
Study Completion Date2029-02-01

Terms related to this study

Keywords Provided by Researchers

  • Pediatrics
  • Mechanical Ventilation
  • Inhaled Nitric Oxide

Additional Relevant MeSH Terms

  • Acute Respiratory Distress Syndrome