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Sponsored by: |
University of Chicago |
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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 |
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Pulmonary Hypertension |
Drug: Inhaled 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:
United States, Illinois | |
Comer Children's Hospital, The University of Chicago Hospitals | |
Chicago, Illinois, United States, 60637 | |
Israel | |
Shaare Zedek Medical Center | |
Jerusalem, Israel, 91031 |
Principal Investigator: | Michael D Schreiber, MD | University of Chicago |
Responsible Party: | University of Chicago ( Michael D. Schreiber, M.D. ) |
Study ID Numbers: | 14479B |
Study First Received: | December 7, 2006 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00409526 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Iloprost PPHN Newborn |
Pulmonary Hypertension Term Persistent Pulmonary Hypertension of the Newborn |
Iloprost Vasodilator Agents Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Vascular Diseases Persistent Fetal Circulation Syndrome Platelet Aggregation Inhibitors Cardiovascular Agents Hypertension |
Vasodilator Agents Hematologic Agents Vascular Diseases Cardiovascular Agents Pharmacologic Actions Iloprost Respiratory Tract Diseases |
Hypertension, Pulmonary Lung Diseases Therapeutic Uses Cardiovascular Diseases Platelet Aggregation Inhibitors Hypertension |