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



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

For Condition: Respiratory Insufficiency,Anoxemia
Status: Recruiting
Sponsor(s): INO Therapeutics ,
Synopsis: 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.
Details: 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 assesssment.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /16 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Admitted to pediatric intensive care unit and have the diagnosis of acute repiratory 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
Total Enrollment: 350

Location and Contact Information:

The Children's Hospital *Recruiting*
Denver,  Colorado,  80218
United States
Recruiting Emily  Dobyns

New York Presbyterian Hospital *Not yet recruiting*
New York City,  New York,  10021
United States
Not yet recruiting H.  Ushay

University of Chicago, Children's Hospital *Recruiting*
Chicago,  Illinois,  60637
United States
Recruiting Michael  Schrieber

Oregon Health and Science University *Recruiting*
Portland,  Oregon,  97239
United States
Recruiting Dana  Braner

The Medical University of South Carolina *Not yet recruiting*
Charleston,  South Carolina,  29425
United States
Not yet recruiting David  Habib

Vanderbilt University Medical Center *Recruiting*
Nashville,  Tennessee,  37232
United States
Recruiting Neal  Patel

Children's Healthcare of Atlanta at Egleston *Recruiting*
Atlanta,  Georgia,  30322
United States
Recruiting James  Fortenberry

Chrildren's Hospital of Orange County *Recruiting*
Orange,  California,  92868
United States
Recruiting Ronald  Bronicki


Additional Information:
Study ID Numbers:
  INOT-11; 
Study Start Date: January 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041561

Other Respiratory Insufficiency Studies:
1. Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics

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