NCT00196469

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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

Conditions

• Respiration, Artificial
• Hemorrhage

Interventions

Type	Name	Description
DRUG	heparin

Timeline

• Start date: 2003-12-01
• Completion: 2007-03-01
• First posted: 2005-09-20
• Last updated: 2007-10-23

Locations

1 site across 1 country: Germany