Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants.
- Conditions
- Pulmonary Hypertension
- Registration Number
- NCT00409526
- Lead Sponsor
- University of Chicago
- 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- Near-term infants (>34 gestational age) with evidence of persistent pulmonary hypertension and severe hypoxia(PaO2<100 mmHg with mechanical ventilation with FiO2=100%).
- Major congenital malformation
- Congenital diaphragmatic hernia
- Structural cardiac anomalies
- Hydrops fetalis
- Pulmonary hemorrhage
- Severe perinatal depression
- Patients on high frequency oscillation ventilator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Oxygenation index and PaO2 after treatment with inhaled Iloprost. three hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Comer Children's Hospital, The University of Chicago Hospitals
🇺🇸Chicago, Illinois, United States