Status:
TERMINATED
Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants.
Lead Sponsor:
University of Chicago
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
Up to 7 years
Phase:
PHASE4
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 arter...
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...
Eligibility Criteria
Inclusion
- Near-term infants (\>34 gestational age) with evidence of persistent pulmonary hypertension and severe hypoxia(PaO2\<100 mmHg with mechanical ventilation with FiO2=100%).
Exclusion
- Major congenital malformation
- Congenital diaphragmatic hernia
- Structural cardiac anomalies
- Hydrops fetalis
- Pulmonary hemorrhage
- Severe perinatal depression
- Patients on high frequency oscillation ventilator
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00409526
Start Date
December 1 2006
End Date
December 1 2007
Last Update
June 2 2014
Active Locations (2)
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1
Comer Children's Hospital, The University of Chicago Hospitals
Chicago, Illinois, United States, 60637
2
Shaare Zedek Medical Center
Jerusalem, Israel, 91031