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Impact of Heparin on the Need for Mechanical Ventilation in Neonates

Primary Purpose

Respiration, Artificial, Hemorrhage

Status

Unknown status

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

heparin

About this trial

This is an interventional prevention trial for Respiration, Artificial

Eligibility Criteria

undefined - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Newborns < day 28 of life Necessity for intensive care treatment Necessity for parenteral drug or fluid application for at least five days Informed consent of parents Exclusion Criteria: Body weight < 500g Mechanical ventilation directly after birth Major malformations Absolute indication for heparin Inborn hemorrhagic disease (e.g. hemophilia, von Willebrand disease) Cerebral bleeding or other major bleeding Platelet count < 50,000/µl

Sites / Locations

University Hospital Department of Pediatrics/Institute for Immunology and Transfusion MedicineRecruiting

Outcomes

Primary Outcome Measures

percentage of neonates requiring mechanical ventilation

Secondary Outcome Measures

duration of dependency on mechanical ventilation

major bleeding

heparin induced thrombocytopenia

anti PF4/heparin antibodies

Full Information

NCT ID

NCT00196469

First Posted

September 12, 2005

Last Updated

October 22, 2007

Sponsor

University Medicine Greifswald

1. Study Identification

Unique Protocol Identification Number

NCT00196469

Brief Title

Impact of Heparin on the Need for Mechanical Ventilation in Neonates

Official Title

Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Unknown status

Study Start Date

December 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Medicine Greifswald

4. Oversight

5. Study Description

Brief Summary

This study is designed to test an incidental finding of a previous trial in which post hoc analysis showed that the rate of intensive care newborns requiring mechanical ventilation was lower in the group receiving heparin with the continuous infusion as compared to the placebo group.

Detailed Description

Title: Randomized double blind trial comparing heparin and placebo as additives to continuous infusion in intensive care neonates for prevention of mechanical ventilation Primary endpoint: Percentage of neonates requiring mechanical ventilation in both groups Secondary endpoints: Duration of dependency on mechanical ventilation; major bleedings, incidence of heparin-induced thrombocytopenia and of anti-platelet factor 4/heparin antibodies

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiration, Artificial, Hemorrhage

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

270 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

heparin

Primary Outcome Measure Information:

Title

percentage of neonates requiring mechanical ventilation

Secondary Outcome Measure Information:

Title

duration of dependency on mechanical ventilation

Title

major bleeding

Title

heparin induced thrombocytopenia

Title

anti PF4/heparin antibodies

10. Eligibility

Sex

All

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andreas Greinacher, MD

greinach@uni-greifswald.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Greinacher, MD

Organizational Affiliation

Institute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University Greifswald

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Christoph Fusch, MD

Organizational Affiliation

Pediatric Department, Ernst-Moritz-Arndt-University Greifswald

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Anne F Klenner, MD

Organizational Affiliation

Medical Faculty, Ernst-Moritz-Arndt University Greifswald

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine

City

Greifswald

ZIP/Postal Code

17487

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andreas Greinacher, MD

Phone

+49 3834-865482

greinach@uni-greifswald.de

First Name & Middle Initial & Last Name & Degree

Christoph Fusch, MD

Phone

+49-3834-866420

fusch@uni-greifswald.de

First Name & Middle Initial & Last Name & Degree

Andreas Greinacher, MD

First Name & Middle Initial & Last Name & Degree

Christoph Fusch, MD

First Name & Middle Initial & Last Name & Degree

Anne F Klenner, MD

12. IPD Sharing Statement

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Impact of Heparin on the Need for Mechanical Ventilation in Neonates

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