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Sponsored by: |
University of Chicago |
Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00409526 |
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.
Condition | Intervention |
Pulmonary Hypertension |
Drug: Inhaled Iloprost |
Genetics Home Reference related topics: | pulmonary arterial hypertension |
MedlinePlus related topics: | High Blood Pressure Pulmonary Hypertension |
Drug Information available for: | Iloprost |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study: The Effect of Inhaled Iloprost on Oxygenation in Term and Near Term Infants With Pulmonary Hypertension. Testing Two Doses. |
Estimated Enrollment: | 40 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | up to 7 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael D Schreiber, MD | 773-702-6210 | mdschrei@uchicago.edu |
Contact: Alona Bin-Nun, MD | 773-702-6210 | alona.bin-nun@uchospitals.edu |
United States, Illinois | |||||
Comer Children's Hospital, The University of Chicago Hospitals | Recruiting | ||||
Chicago, Illinois, United States, 60637 | |||||
Contact: Michael D Schreiber, MD 773-702-6210 mdschrei@uchicago.edu | |||||
Contact: Alona Bin-Nun, MD 773-702-6210 alona.bin-nun@uchospitals.edu | |||||
Principal Investigator: Michael D Schreiber, MD | |||||
Sub-Investigator: Alona Bin-Nun, MD | |||||
Sub-Investigator: Vitaliy Soloveychik, MD | |||||
Israel | |||||
Shaare Zedek Medical Center | Not yet recruiting | ||||
Jerusalem, Israel, 91031 | |||||
Contact: Cathy Hammerman, MD 972-2-666-6238 cathy@cc.huji.ac.il | |||||
Principal Investigator: Cathy Hammerman, MD |
University of Chicago |
Principal Investigator: | Michael D Schreiber, MD | University of Chicago |
Responsible Party: | University of Chicago ( Michael D. Schreiber, M.D. ) |
Study ID Numbers: | 14479B |
First Received: | December 7, 2006 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00409526 |
Health Authority: | United States: Food and Drug Administration |
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