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

Primary Purpose

Respiratory Insufficiency, Anoxemia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nitrogen gas
inhaled nitric oxide
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Acute hypoxemic respiratory failure

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chrildren's Hospital of Orange County
  • Stanford University Medical Center
  • The Children's Hospital
  • Nemours Children's Clinic
  • Children's Healthcare of Atlanta at Egleston
  • University of Chicago, Children's Hospital
  • Louisiana State University Health Sciences Center - Shreveport
  • The Johns Hopkins Hospital
  • Children's Hospital at Montefiore
  • New York Presbyterian Hospital
  • Children's Hospital Medical Center of Akron
  • The Cleveland Clinic Foundation
  • Children's Hospital
  • Oregon Health and Science University
  • The Medical University of South Carolina
  • University of Virginia Pediatric Critical Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

Nitrogen gas

Inhaled Nitric Oxide

Outcomes

Primary Outcome Measures

arterial blood gases

Secondary Outcome Measures

methemoglobin
broncho-alveolar lavage fluid
Prone position

Full Information

First Posted
July 10, 2002
Last Updated
July 22, 2016
Sponsor
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT00041561
Brief Title
Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics
Official Title
The Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) In Pediatrics
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Study stopped due to poor enrollment
Study Start Date
January 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Anoxemia
Keywords
Acute hypoxemic respiratory failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Nitrogen gas
Arm Title
1
Arm Type
Experimental
Arm Description
Inhaled Nitric Oxide
Intervention Type
Drug
Intervention Name(s)
Nitrogen gas
Intervention Description
Nitrogen gas will be given at 5ppm until Day 28 or extubation
Intervention Type
Drug
Intervention Name(s)
inhaled nitric oxide
Other Intervention Name(s)
INOmax®
Intervention Description
inhaled nitric oxide will be given at 5 ppm until day 28 or extubation
Primary Outcome Measure Information:
Title
arterial blood gases
Time Frame
baseline through 24 hours and extubation
Secondary Outcome Measure Information:
Title
methemoglobin
Time Frame
baseline, hour 4 and 24 hours
Title
broncho-alveolar lavage fluid
Time Frame
baseline, 48 hours and day 5
Title
Prone position
Time Frame
baseline then daily

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Baldassarre, MD
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Chrildren's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
The Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Nemours Children's Clinic
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Children's Healthcare of Atlanta at Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago, Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Virginia Pediatric Critical Care
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

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

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