Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants. - Full Text View

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

Genetics Home Reference related topics:

pulmonary arterial hypertension

MedlinePlus related topics:

High Blood Pressure Pulmonary Hypertension

Drug Information available for:

Iloprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Pilot Study: The Effect of Inhaled Iloprost on Oxygenation in Term and Near Term Infants With Pulmonary Hypertension. Testing Two Doses.

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:

50 micrograms for one hour followed by 100 micrograms for one hour

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

Contacts


Contact: Michael D Schreiber, MD	773-702-6210	mdschrei@uchicago.edu

Contact: Alona Bin-Nun, MD	773-702-6210	alona.bin-nun@uchospitals.edu

Locations


United States, Illinois
	Comer Children's Hospital, The University of Chicago Hospitals	Recruiting
	Chicago, Illinois, United States, 60637
	Contact: Michael D Schreiber, MD 773-702-6210 mdschrei@uchicago.edu
	Contact: Alona Bin-Nun, MD 773-702-6210 alona.bin-nun@uchospitals.edu
	Principal Investigator: Michael D Schreiber, MD
	Sub-Investigator: Alona Bin-Nun, MD
	Sub-Investigator: Vitaliy Soloveychik, MD

Israel
	Shaare Zedek Medical Center	Not yet recruiting
	Jerusalem, Israel, 91031
	Contact: Cathy Hammerman, MD 972-2-666-6238 cathy@cc.huji.ac.il
	Principal Investigator: Cathy Hammerman, MD

Sponsors and Collaborators

University of Chicago

Investigators


Principal Investigator:	Michael D Schreiber, MD	University of Chicago

More Information

Responsible Party:	University of Chicago ( Michael D. Schreiber, M.D. )
Study ID Numbers:	14479B
First Received:	December 7, 2006
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00409526
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

Study placed in the following topic categories:

Iloprost

Respiratory Tract Diseases

Hypertension, Pulmonary

Lung Diseases

Vascular Diseases

Persistent Fetal Circulation Syndrome

Hypertension

Additional relevant MeSH terms:

Vasodilator Agents

Therapeutic Uses

Hematologic Agents

Platelet Aggregation Inhibitors

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00409526