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

Respiratory Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00041561
• Other study ID #: INOT-11
• Status: Terminated
• Phase: Phase 3
• First received: July 10, 2002
• Last updated: July 22, 2016
• Start date: January 2002
• Est. completion date: December 2004

Study information

• Verified date: July 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anoxemia
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Drug:
• Nitrogen gas
Nitrogen gas will be given at 5ppm until Day 28 or extubation
• inhaled nitric oxide
inhaled nitric oxide will be given at 5 ppm until day 28 or extubation

Locations

Country	Name	City	State
United States	Children's Hospital Medical Center of Akron	Akron	Ohio
United States	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	Children's Hospital at Montefiore	Bronx	New York
United States	The Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia Pediatric Critical Care	Charlottesville	Virginia
United States	University of Chicago, Children's Hospital	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Children's Hospital	Columbus	Ohio
United States	The Children's Hospital	Denver	Colorado
United States	New York Presbyterian Hospital	New York	New York
United States	Chrildren's Hospital of Orange County	Orange	California
United States	Nemours Children's Clinic	Orlando	Florida
United States	Oregon Health and Science University	Portland	Oregon
United States	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial blood gases		baseline through 24 hours and extubation	Yes
Secondary	methemoglobin		baseline, hour 4 and 24 hours	Yes
Secondary	broncho-alveolar lavage fluid		baseline, 48 hours and day 5	No
Secondary	Prone position		baseline then daily	No