Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041561
Status:
TERMINATED
Last Update Posted:
2016-07-26
First Post:
2002-07-10
Brief Title:
Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure AHRF in Pediatrics
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
The Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure AHRF In Pediatrics
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped due to poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None