Back to resultsInhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants.
Primary Purpose
Pulmonary Hypertension
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Inhaled Iloprost
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Iloprost, PPHN, Newborn, Pulmonary Hypertension, Term, Persistent Pulmonary Hypertension of the Newborn
Eligibility 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
Sites / Locations
- Comer Children's Hospital, The University of Chicago Hospitals
- Shaare Zedek Medical Center
Outcomes
Primary Outcome Measures
Oxygenation index and PaO2 after treatment with inhaled Iloprost.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00409526
Brief Title
Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants.
Official Title
Pilot Study: The Effect of Inhaled Iloprost on Oxygenation in Term and Near Term Infants With Pulmonary Hypertension. Testing Two Doses.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Sub-Investigator left U of C
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Iloprost, PPHN, Newborn, Pulmonary Hypertension, Term, Persistent Pulmonary Hypertension of the Newborn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Inhaled Iloprost
Other Intervention Name(s)
Ventavis
Intervention Description
50 micrograms for one hour followed by 100 micrograms for one hour
Primary Outcome Measure Information:
Title
Oxygenation index and PaO2 after treatment with inhaled Iloprost.
Time Frame
three hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Schreiber, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comer Children's Hospital, The University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants.
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