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Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics | Clinical Trials | Clareo Health

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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

NCT00041561•Mallinckrodt

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 16 years

Sex

ALL

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

Locations (16)

Chrildren's Hospital of Orange County

Orange, California, United States

Stanford University Medical Center

Stanford, California, United States

The Children's Hospital

Denver, Colorado, United States

Nemours Children's Clinic

Orlando, Florida, United States

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, United States

University of Chicago, Children's Hospital

Chicago, Illinois, United States

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

New York Presbyterian Hospital

New York, New York, United States

Children's Hospital at Montefiore

The Bronx, New York, United States

Key Dates

Start Date

January 1, 2002

Primary Completion Date

December 1, 2004

Completion Date

December 1, 2004

Last Updated

July 26, 2016

Enrollment

ACTUAL participants

Conditions

Respiratory InsufficiencyAnoxemia

Interventions

Nitrogen gas

DRUG

inhaled nitric oxide

DRUG

Comparison of Transcutaneous and Blood CO₂ Measurement in Critically Ill Children

NCT07468006

Respiratory Insufficiency in Children

View study

RECRUITINGNA

Platform of Randomized Adaptive Clinical Trials in Critical Illness

NCT05440851

Respiratory InsufficiencyExtracorporeal Membrane Oxygenation Complication+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 26, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Comparison of Transcutaneous and Blood CO₂ Measurement in Critically Ill Children

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