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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)
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: December 7, 2006
Last updated: May 30, 2014
Last verified: May 2014
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.

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

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
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Please refer to this study by its identifier: NCT00409526

United States, Illinois
Comer Children's Hospital, The University of Chicago Hospitals
Chicago, Illinois, United States, 60637
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
University of Chicago
Principal Investigator: Michael D Schreiber, MD University of Chicago
  More Information

Responsible Party: University of Chicago Identifier: NCT00409526     History of Changes
Other Study ID Numbers: 14479B
Study First Received: December 7, 2006
Last Updated: May 30, 2014

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

Additional relevant MeSH terms:
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents processed this record on September 19, 2017