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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of Chicago.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00409526
First received: December 7, 2006
Last updated: April 24, 2009
Last verified: April 2009
History of Changes
  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
Pulmonary Hypertension
 Drug: Inhaled Iloprost

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Iloprost
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2006
Estimated Primary Completion Date: June 2009 (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

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michael D. Schreiber, M.D., University of Chicago
ClinicalTrials.gov Identifier: NCT00409526     History of Changes
Other Study ID Numbers: 14479B
Study First Received: December 7, 2006
Last Updated: April 24, 2009
Health Authority: United States: Food and Drug Administration

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013