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

Sponsoren

Hauptsponsor: Mallinckrodt

Quelle Mallinckrodt
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Terminated
Anfangsdatum January 2002
Fertigstellungstermin December 2004
Primäres Abschlussdatum December 2004
Phase Phase 3
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
arterial blood gases baseline through 24 hours and extubation
Sekundäres Ergebnis
Messen Zeitfenster
methemoglobin baseline, hour 4 and 24 hours
broncho-alveolar lavage fluid baseline, 48 hours and day 5
Prone position baseline then daily
Einschreibung 55
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Nitrogen gas

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

Armgruppenetikett: 2

Interventionsart: Drug

Interventionsname: inhaled nitric oxide

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

Armgruppenetikett: 1

Anderer Name: INOmax®

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: N/A

Maximales Alter: 16 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
James Baldassarre, MD Study Director Mallinckrodt
Ort
Einrichtung:
Chrildren's Hospital of Orange County | Orange, California, 92868, United States
Stanford University Medical Center | Stanford, California, 94305, United States
The Children's Hospital | Denver, Colorado, 80218, United States
Nemours Children's Clinic | Orlando, Florida, 32806, United States
Children's Healthcare of Atlanta at Egleston | Atlanta, Georgia, 30322, United States
University of Chicago, Children's Hospital | Chicago, Illinois, 60637, United States
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana, 71103, United States
The Johns Hopkins Hospital | Baltimore, Maryland, 21287, United States
Children's Hospital at Montefiore | Bronx, New York, 10467, United States
New York Presbyterian Hospital | New York, New York, 10021, United States
Children's Hospital Medical Center of Akron | Akron, Ohio, 44308, United States
The Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States
Children's Hospital | Columbus, Ohio, 43205, United States
Oregon Health and Science University | Portland, Oregon, 97239, United States
The Medical University of South Carolina | Charleston, South Carolina, 29425, United States
University of Virginia Pediatric Critical Care | Charlottesville, Virginia, 22908, United States
Standort Länder

United States

Überprüfungsdatum

July 2016

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: 2

Art: Placebo Comparator

Beschreibung: Nitrogen gas

Etikette: 1

Art: Experimental

Beschreibung: Inhaled Nitric Oxide

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Triple (Participant, Care Provider, Investigator)

Quelle: ClinicalTrials.gov