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Clinical Trials/NCT00409526
NCT00409526TerminatedPhase 4

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

University of Chicago4 sites in 2 countries1 target enrollmentStarted: December 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Terminated
Enrollment
1
Locations
4
Primary Endpoint
Oxygenation index and PaO2 after treatment with inhaled Iloprost.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 7 Days (Child)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Oxygenation index and PaO2 after treatment with inhaled Iloprost.

Time Frame: three hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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