Recruiting

Inhaled Nitric Oxide

Sponsor:

Children's Hospital Los Angeles

Code:

NCT06690801

Conditions

Acute Respiratory Distress Syndrome

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Acute Respiratory Distress Syndrome

Study ID

NCT06690801

Start date

Oct 3, 2024

Status verified date

Nov, 2024

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1260 participants

Anticipated

Interventions and Outcome Measures

Arms

Children with moderate to severe ARDS

Primary outcome measure

  • Number of participants that experience all-cause mortality within 28 days from start of invasive mechanical ventilation [ Time Frame: From the start of invasive mechanical ventilation to 28 days ]

Central Contacts and Locations

Central contacts

Jeni Kwok

3233617939dinostudy@chla.usc.edu

Anoopindar Bhalla, MD

3233617939abhalla@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Jeni Kwok, JD

323-660-2450ymkwok@chla.usc.edu

Principal Investigator:

Anoopindar Bhalla, MD

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Nov 15, 2024

Last verified

Nov, 2024

Keywords

  • Pediatrics
  • Mechanical Ventilation
  • Inhaled Nitric Oxide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2024-11-15.