Impact of Heparin on the Need for Mechanical Ventilation in Neonates
- Conditions
- Respiration, ArtificialHemorrhage
- Registration Number
- NCT00196469
- Lead Sponsor
- University Medicine Greifswald
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 270
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method percentage of neonates requiring mechanical ventilation
- Secondary Outcome Measures
Name Time Method duration of dependency on mechanical ventilation major bleeding heparin induced thrombocytopenia anti PF4/heparin antibodies
Trial Locations
- Locations (1)
University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine
🇩🇪Greifswald, Germany