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Impact of Heparin on the Need for Mechanical Ventilation in Neonates

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by University Medicine Greifswald.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196469
First Posted: September 20, 2005
Last Update Posted: October 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Medicine Greifswald
  Purpose
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.

Condition Intervention Phase
Respiration, Artificial Hemorrhage Drug: heparin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation

Resource links provided by NLM:


Further study details as provided by University Medicine Greifswald:

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

Estimated Enrollment: 270
Study Start Date: December 2003
Estimated Study Completion Date: March 2007
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196469


Contacts
Contact: Andreas Greinacher, MD greinach@uni-greifswald.de

Locations
Germany
University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine Recruiting
Greifswald, Germany, 17487
Contact: Andreas Greinacher, MD    +49 3834-865482    greinach@uni-greifswald.de   
Contact: Christoph Fusch, MD    +49-3834-866420    fusch@uni-greifswald.de   
Principal Investigator: Andreas Greinacher, MD         
Principal Investigator: Christoph Fusch, MD         
Sub-Investigator: Anne F Klenner, MD         
Sponsors and Collaborators
University Medicine Greifswald
Investigators
Study Chair: Andreas Greinacher, MD Institute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University Greifswald
Study Director: Christoph Fusch, MD Pediatric Department, Ernst-Moritz-Arndt-University Greifswald
Principal Investigator: Anne F Klenner, MD Medical Faculty, Ernst-Moritz-Arndt University Greifswald
  More Information

ClinicalTrials.gov Identifier: NCT00196469     History of Changes
Other Study ID Numbers: EMAU16253.00.00
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: October 23, 2007
Last Verified: September 2006

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action