Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409526
Status:
TERMINATED
Last Update Posted:
2014-06-02
First Post:
2006-12-07
Brief Title:
Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Pilot Study The Effect of Inhaled Iloprost on Oxygenation in Term and Near Term Infants With Pulmonary Hypertension Testing Two Doses
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sub-Investigator left U of C
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Inhaled Iloprost will be administered to near term infants with Persistent Pulmonary Hypertension of the Newborn in two different doses in order to test safety and efficacy in reducing pulmonary artery pressure
Detailed Description:
Infants eligible for the study will be divided into two arms according to oxygenation index Infants in arm A OI 20 will receive nebulized Iloprost in a lower dose 50 ngkgmin for one hour and a higher dose 100 ngkgmin for another hour Infants in arm B OI20 will receive NO and in addition will receive nebulized Iloprost in a lower dose for one hour and a higher dose for another hour
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