Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196469
Status:
UNKNOWN
Last Update Posted:
2007-10-23
First Post:
2005-09-12
Brief Title:
Impact of Heparin on the Need for Mechanical Ventilation in Neonates
Sponsor:
University Medicine Greifswald
Organization:
University Medicine Greifswald
Study Overview
Official Title:
Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 4heparin antibodies
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 4heparin antibodies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None