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

Phase 4TerminatedNCT00409526

University of Chicago1 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Hypertension

Interventions

Inhaled IloprostDRUG

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

Eligibility

Sex: ALLMax age: 7 Days

Medical Language ↔ Plain English

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

Locations (2)

Comer Children's Hospital, The University of Chicago Hospitals

Chicago, Illinois, United States

Shaare Zedek Medical Center

Jerusalem, Israel

Outcomes

Primary Outcomes

Oxygenation index and PaO2 after treatment with inhaled Iloprost.

Time frame: three hours

Data from ClinicalTrials.gov

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