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

The University of Chicago

Status and phase: Terminated; Phase 4

Conditions: Pulmonary Hypertension

Treatments: Drug: Inhaled Iloprost

Study type: Interventional

Funder types: Other

Identifiers

NCT00409526

14479B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)