Impact of Heparin on the Need for Mechanical Ventilation in Neonates

University Medicine Greifswald

Status and phase: Unknown; Phase 4

Conditions: Hemorrhage; Respiration, Artificial

Treatments: Drug: heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT00196469

EMAU16253.00.00

Details and patient eligibility

About

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.

Full 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

Enrollment: 270 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind