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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00409526
• Other study ID #: 14479B
• Status: Terminated
• Phase: Phase 4
• First received: December 7, 2006
• Last updated: May 30, 2014
• Start date: December 2006
• Est. completion date: December 2007

Study information

• Verified date: May 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Inhaled Iloprost
50 micrograms for one hour followed by 100 micrograms for one hour

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem
United States	Comer Children's Hospital, The University of Chicago Hospitals	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation index and PaO2 after treatment with inhaled Iloprost.		three hours	Yes