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Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants.

This study has been terminated.
(Sub-Investigator left U of C)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00409526
First received: December 7, 2006
Last updated: May 30, 2014
Last verified: May 2014

December 7, 2006
May 30, 2014
December 2006
December 2007   (final data collection date for primary outcome measure)
Oxygenation index and PaO2 after treatment with inhaled Iloprost. [ Time Frame: three hours ] [ Designated as safety issue: Yes ]
Oxygenation index and PaO2 after treatment with inhaled Iloprost.
Complete list of historical versions of study NCT00409526 on ClinicalTrials.gov Archive Site
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Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants.
Pilot Study: The Effect of Inhaled Iloprost on Oxygenation in Term and Near Term Infants With Pulmonary Hypertension. Testing Two Doses.

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Hypertension
Drug: Inhaled Iloprost
50 micrograms for one hour followed by 100 micrograms for one hour
Other Name: Ventavis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • Major congenital malformation
  • Congenital diaphragmatic hernia
  • Structural cardiac anomalies
  • Hydrops fetalis
  • Pulmonary hemorrhage
  • Severe perinatal depression
  • Patients on high frequency oscillation ventilator
Both
up to 7 Days
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel
 
NCT00409526
14479B
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University of Chicago
University of Chicago
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Principal Investigator: Michael D Schreiber, MD University of Chicago
University of Chicago
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP