NCT00409526

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_4

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

December 7, 2006

Last Update Submit

May 30, 2014

Conditions

Pulmonary Hypertension

Keywords

IloprostPPHNNewbornPulmonary HypertensionTermPersistent Pulmonary Hypertension of the Newborn

Outcome Measures

Primary Outcomes (1)

  • Oxygenation index and PaO2 after treatment with inhaled Iloprost.

    three hours

Interventions

Inhaled IloprostDRUG

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

Also known as: Ventavis

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Near-term infants (\>34 gestational age) with evidence of persistent pulmonary hypertension and severe hypoxia(PaO2\<100 mmHg with mechanical ventilation with FiO2=100%).

You may not qualify if:

  • Major congenital malformation
  • Congenital diaphragmatic hernia
  • Structural cardiac anomalies
  • Hydrops fetalis
  • Pulmonary hemorrhage
  • Severe perinatal depression
  • Patients on high frequency oscillation ventilator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Comer Children's Hospital, The University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Hypertension, PulmonaryPersistent Fetal Circulation Syndrome

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Michael D Schreiber, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 11, 2006

Study Start

December 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

US(1)IL(1)