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Impact of Heparin on the Need for Mechanical Ventilation in Neonates

NCT ID: NCT00196469

Last Updated: 2007-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2007-03-31

Brief Summary

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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

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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

Conditions

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Respiration, Artificial Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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heparin

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Principal Investigators

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Andreas Greinacher, MD

Role: STUDY_CHAIR

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

Christoph Fusch, MD

Role: STUDY_DIRECTOR

Pediatric Department, Ernst-Moritz-Arndt-University Greifswald

Anne F Klenner, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Faculty, Ernst-Moritz-Arndt University Greifswald

Locations

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

Greifswald, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andreas Greinacher, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Andreas Greinacher, MD

Role: primary

Christoph Fusch, MD

Role: backup

Other Identifiers

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EMAU16253.00.00

Identifier Type: -

Identifier Source: org_study_id