We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00409526
First Posted: December 11, 2006
Last Update Posted: June 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
December 7, 2006
December 11, 2006
June 2, 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 ]
Oxygenation index and PaO2 after treatment with inhaled Iloprost.
Complete list of historical versions of study NCT00409526 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Single Group Assignment
Masking: None (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
Not Provided
Not Provided

*   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
Sexes Eligible for Study: All
up to 7 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Israel,   United States
 
 
NCT00409526
14479B
Not Provided
Not Provided
Not Provided
University of Chicago
University of Chicago
Not Provided
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