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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT06690801
Status
Recruiting
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Conditions

  • Acute Respiratory Distress Syndrome

Eligibility Criteria

Sex
ALL
Age
0 Years - 21 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Oct 3, 2024
Status verified
Nov 2024
Primary completion
Dec 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
1,260 participants (estimated)

Arms

  • Arm: 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

Locations (10)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Jeni Kwok, JD
[email protected]
323-660-2450
Anoopindar Bhalla, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital ColoradoDenverColorado80204
Aline Maddux
[email protected]
Aline Maddux, MD (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02115
Sally Vitali
[email protected]
Sally Vitali, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan / CS Mott Children's HospitalAnn ArborMichigan48109-
University of Nebraska Medical Center / Children's Hospital and Medical CenterOmahaNebraska68198
Eleanor Gradidge
[email protected]
Eleanor Gradidge, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Steve Standage
[email protected]
Steve Standage, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Adam Himebauch
[email protected]
Adam Himebauch, MD (PRINCIPAL_INVESTIGATOR)
Texas Children's Hospital Baylor College of MedicineHoustonTexas77030
Manpreet Virk
[email protected]
Manpreet Virk, MD (PRINCIPAL_INVESTIGATOR)
American Family Children's Hospital / University of Wisconsin-MadisonMadisonWisconsin53792
Awni Al-Subu
[email protected]
Awni Al-Subu, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Wisconsin / Medical College of WisconsinMilwaukeeWisconsin53226
Jasmine Dowell
[email protected]
Jasmine Dowell, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CAChildren's Hospital Colorado· Denver, COBoston Children's Hospital· Boston, MAUniversity of Michigan / CS Mott Children's Hospital· Ann Arbor, MIUniversity of Nebraska Medical Center / Children's Hospital and Medical Center· Omaha, NECincinnati Children's Hospital Medical Center· Cincinnati, OH

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