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

Tracking Information

First Received Date ^ICMJE

July 10, 2002

Last Updated Date

January 9, 2009

Start Date ^ICMJE

January 2002

Primary Completion Date

December 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

arterial blood gases [ Time Frame: baseline through 24 hours and extubation ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00041561 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

methemoglobin [ Time Frame: baseline, hour 4 and 24 hours ] [ Designated as safety issue: Yes ]
broncho-alveolar lavage fluid [ Time Frame: baseline, 48 hours and day 5 ] [ Designated as safety issue: No ]
Prone position [ Time Frame: baseline then daily ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Respiratory Insufficiency
Anoxemia

Intervention ^ICMJE

Drug: Nitrogen gas
Drug: inhaled nitric oxide

Study Arms / Comparison Groups

Placebo Comparator: Nitrogen gas
Experimental: Inhaled Nitric Oxide

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2004

Primary Completion Date

December 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00041561

Responsible Party

James Baldassarre, INO Therapeutics

Study ID Numbers ^ICMJE

INOT-11

Study Sponsor ^ICMJE

INO Therapeutics

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

James Baldassarre, MD

INO Therapeutics

Information Provided By

INO Therapeutics

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP