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TERMINATEDPhase 4NCT00409526

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

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 arter...

Lead sponsor: University of Chicago•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Chicago

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.

Age

0 - 0 years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 2, 2014Terms

Trial snapshot

StatusTERMINATED

PhasePHASE4

Enrollment1

Start dateDec 2006

Last updatedJun 2, 2014

Condition

Pulmonary Hypertension

Locations shown

Comer Children's Hospital, The University of Chicago Hospitals

Chicago, Illinois

Shaare Zedek Medical Center

Jerusalem

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 2, 2014Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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