Inhaled Iloprost for the Treatment of Persistent Pulmonar... | NCT00409526

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

NCT00409526

Sponsor

University of Chicago

Status

Terminated

Last Update Posted

Jun 2, 2014Estimated

Enrollment

1Actual

Phase

Phase 4

Conditions

Pulmonary Hypertension

Interventions

Inhaled Iloprost

Countries

United States
Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sub-Investigator left U of C

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Dec 7, 2006

First Submission Date that Met QC Criteria

Dec 8, 2006

First Posted Date

Dec 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2014

Last Update Posted Date

Jun 2, 2014Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inhaled Iloprost	Drug	50 micrograms for one hour followed by 100 micrograms for one hour		Ventavis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael D Schreiber, MD	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Comer Children's Hospital, The University of Chicago Hospitals		Chicago	Illinois	60637	United States

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary
D010547	Persistent Fetal Circulation Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016285	Iloprost

Ancestor Terms

ID	Term
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated

Browse Leaves

Not provided

Browse Branches

Not provided