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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:
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
  Purpose
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 Phase
Pulmonary Hypertension Drug: Inhaled Iloprost Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: The Effect of Inhaled Iloprost on Oxygenation in Term and Near Term Infants With Pulmonary Hypertension. Testing Two Doses.

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Oxygenation index and PaO2 after treatment with inhaled Iloprost. [ Time Frame: three hours ]

Enrollment: 1
Study Start Date: December 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Inhaled Iloprost
    50 micrograms for one hour followed by 100 micrograms for one hour
    Other Name: Ventavis
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409526


Locations
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
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Michael D Schreiber, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00409526     History of Changes
Other Study ID Numbers: 14479B
First Submitted: December 7, 2006
First Posted: December 11, 2006
Last Update Posted: June 2, 2014
Last Verified: May 2014

Keywords provided by University of Chicago:
Iloprost
PPHN
Newborn
Pulmonary Hypertension
Term
Persistent Pulmonary Hypertension of the Newborn

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents