Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants.
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study: The Effect of Inhaled Iloprost on Oxygenation in Term and Near Term Infants With Pulmonary Hypertension. Testing Two Doses.|
- Oxygenation index and PaO2 after treatment with inhaled Iloprost. [ Time Frame: three hours ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Drug: Inhaled Iloprost
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 ng/kg/min) for one hour, and a higher dose (100 ng/kg/min) for another hour. Infants in arm B (OI>20) will receive NO, and in addition will receive nebulized Iloprost in a lower dose for one hour and a higher dose for another hour.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409526
|United States, Illinois|
|Comer Children's Hospital, The University of Chicago Hospitals|
|Chicago, Illinois, United States, 60637|
|Shaare Zedek Medical Center|
|Jerusalem, Israel, 91031|
|Principal Investigator:||Michael D Schreiber, MD||University of Chicago|