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Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics

Sponsor
Mallinckrodt (Industry)
Overall Status
Terminated
CT.gov ID
NCT00041561
Collaborator
(none)
55
Enrollment
16
Locations
2
Arms
35
Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with AHRF.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nitrogen gas
  • Drug: inhaled nitric oxide
 Phase 3

Detailed Description

Patients will receive 5-ppm study gas (nitric oxide for inhalation or placebo) until Day 28 or extubation, whichever comes first. The following will be performed / recorded at specified times during the study: arterial blood gases, ventilator settings, methemoglobin, PRISM III score, and patient positioning. Selected centers will also be performing plasma cytokine assays, broncho-alveolar lavage fluid assays and a 6 month follow-up assessment.

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) In Pediatrics
Study Start Date :
Jan 1, 2002
Actual Primary Completion Date :
Dec 1, 2004
Actual Study Completion Date :
Dec 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 2

Nitrogen gas

Drug: Nitrogen gas
Nitrogen gas will be given at 5ppm until Day 28 or extubation
Experimental: 1

Inhaled Nitric Oxide

Drug: inhaled nitric oxide
inhaled nitric oxide will be given at 5 ppm until day 28 or extubation
Other Names:
  • INOmax®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. arterial blood gases [baseline through 24 hours and extubation]

    Secondary Outcome Measures

    1. methemoglobin [baseline, hour 4 and 24 hours]

    2. broncho-alveolar lavage fluid [baseline, 48 hours and day 5]

    3. Prone position [baseline then daily]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Admitted to pediatric intensive care unit and have the diagnosis of acute respiratory failure

    • 44 weeks post conceptional age to 16 years of age

    • Oxygenation Index (OI) >=12 cm H2O/mmHg (as determined by two separate measurement taken 30 minutes to 4 hours apart)

    • Recent chest x-ray (within 24 hours) showing at least unilateral infiltrations

    • Mechanically ventilated <= 7 days

    Exclusion criteria:

    • Immunocompromised

    • Received a bone marrow transplant

    • Active oncological condition

    • Persistent right to left intracardiac shunt

    • Cardiovascular surgery within the last 14 days

    • Status asthmaticus

    • Decision by primary care physician not to provide full support

    • Received treatment with nitric oxide for inhalation or other investigational medications within 24 hours prior to study initiation, participating in surfactant trials

    • Chronically ventilated

    • Pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chrildren's Hospital of Orange County Orange California United States 92868
    2 Stanford University Medical Center Stanford California United States 94305
    3 The Children's Hospital Denver Colorado United States 80218
    4 Nemours Children's Clinic Orlando Florida United States 32806
    5 Children's Healthcare of Atlanta at Egleston Atlanta Georgia United States 30322
    6 University of Chicago, Children's Hospital Chicago Illinois United States 60637
    7 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71103
    8 The Johns Hopkins Hospital Baltimore Maryland United States 21287
    9 Children's Hospital at Montefiore Bronx New York United States 10467
    10 New York Presbyterian Hospital New York New York United States 10021
    11 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
    12 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
    13 Children's Hospital Columbus Ohio United States 43205
    14 Oregon Health and Science University Portland Oregon United States 97239
    15 The Medical University of South Carolina Charleston South Carolina United States 29425
    16 University of Virginia Pediatric Critical Care Charlottesville Virginia United States 22908

    Sponsors and Collaborators

    • Mallinckrodt

    Investigators

    • Study Director: James Baldassarre, MD, Mallinckrodt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mallinckrodt
    ClinicalTrials.gov Identifier:
    NCT00041561
    Other Study ID Numbers:
    • INOT-11
    First Posted:
    Jul 11, 2002
    Last Update Posted:
    Jul 26, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by Mallinckrodt
    Acute hypoxemic respiratory failure
    Additional relevant MeSH terms:
    Respiratory Insufficiency
    Nitric Oxide

    Study Results

    No Results Posted as of Jul 26, 2016