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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00409526

Enrollment

Registered

2006-12-11

Start date

2006-12-31

Completion date

2007-12-31

Last updated

2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

Iloprost, PPHN, Newborn, Pulmonary Hypertension, Term, Persistent Pulmonary Hypertension of the Newborn

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.

Interventions

DRUGInhaled Iloprost

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Days

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

Design outcomes

Primary

Measure	Time frame
Oxygenation index and PaO2 after treatment with inhaled Iloprost.	three hours

Countries

Israel, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026