Status:
UNKNOWN
Impact of Heparin on the Need for Mechanical Ventilation in Neonates
Lead Sponsor:
University Medicine Greifswald
Conditions:
Respiration, Artificial
Hemorrhage
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE4
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 gr...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00196469
Start Date
December 1 2003
End Date
March 1 2007
Last Update
October 23 2007
Active Locations (1)
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1
University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine
Greifswald, Germany, 17487