Impact of Heparin on the Need for Mechanical Ventilation in Neonates

Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation

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.

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

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