NCT00041561

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2002

Typical duration for phase_3

Geographic Reach
1 country

16 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2002

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

2.9 years

First QC Date

July 10, 2002

Last Update Submit

July 22, 2016

Conditions

Respiratory InsufficiencyAnoxemia

Keywords

Acute hypoxemic respiratory failure

Outcome Measures

Primary Outcomes (1)

  • arterial blood gases

    baseline through 24 hours and extubation

Secondary Outcomes (3)

  • methemoglobin

    baseline, hour 4 and 24 hours

  • broncho-alveolar lavage fluid

    baseline, 48 hours and day 5

  • Prone position

    baseline then daily

Study Arms (2)

2

PLACEBO COMPARATOR

Nitrogen gas

Drug: Nitrogen gas

1

EXPERIMENTAL

Inhaled Nitric Oxide

Drug: inhaled nitric oxide

Interventions

Nitrogen gasDRUG

Nitrogen gas will be given at 5ppm until Day 28 or extubation

2
inhaled nitric oxideDRUG

inhaled nitric oxide will be given at 5 ppm until day 28 or extubation

Also known as: INOmax®
1

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Chrildren's Hospital of Orange County

Orange, California, 92868, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

The Children's Hospital

Denver, Colorado, 80218, United States

Location

Nemours Children's Clinic

Orlando, Florida, 32806, United States

Location

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

University of Chicago, Children's Hospital

Chicago, Illinois, 60637, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71103, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Children's Hospital

Columbus, Ohio, 43205, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

The Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Virginia Pediatric Critical Care

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Respiratory InsufficiencyHypoxia

Interventions

NitrogenEndothelium-Dependent Relaxing Factors

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ElementsInorganic ChemicalsGasesVasodilator AgentsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • James Baldassarre, MD

    Mallinckrodt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2002

First Posted

July 11, 2002

Study Start

January 1, 2002

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

US(16)