Hemorrhage, Respiration, Artificial
Conditions
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
Interventions
DRUGheparin
Sponsors
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of neonates requiring mechanical ventilation | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of dependency on mechanical ventilation | — |
| major bleeding | — |
| heparin induced thrombocytopenia | — |
| anti PF4/heparin antibodies | — |
Countries
Germany
Contacts
Primary ContactAndreas Greinacher, MD
Outcome results
None listed