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

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

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Insufficiency; Anoxemia
• Intervention / Treatment: Drug: Nitrogen gas; Drug: inhaled nitric oxide

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Chrildren's Hospital of Orange County
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Colorado
    • Denver, Colorado, United States, 80218
      • The Children's Hospital
  • Florida
    • Orlando, Florida, United States, 32806
      • Nemours Children's Clinic
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta at Egleston
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago, Children's Hospital
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Louisiana State University Health Sciences Center - Shreveport
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Hospital
  • New York
    • Bronx, New York, United States, 10467
      • Children's Hospital at Montefiore
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital
  • Ohio
    • Akron, Ohio, United States, 44308
      • Children's Hospital Medical Center of Akron
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43205
      • Children's Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • The Medical University of South Carolina
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Pediatric Critical Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
arterial blood gases	baseline through 24 hours and extubation

Secondary Outcome Measures

Outcome Measure	Time Frame
methemoglobin	baseline, hour 4 and 24 hours
broncho-alveolar lavage fluid	baseline, 48 hours and day 5
Prone position	baseline then daily

Collaborators and Investigators

• Sponsor: Mallinckrodt
• Investigators: Study Director: James Baldassarre, MD, Mallinckrodt

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: July 10, 2002
• First Submitted That Met QC Criteria: July 10, 2002
• First Posted (Estimate): July 11, 2002

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 22, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Acute hypoxemic respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: INOT-11