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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Inhaled Iloprost

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

Intervention Type DRUG

Other Intervention Names

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Ventavis

Eligibility Criteria

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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

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No