Impact of Heparin on the Need for Mechanical Ventilation in Neonates

Overview

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Double

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

• Drug: heparin

Clinical Trial Outcome Measures

Primary Measures

• percentage of neonates requiring mechanical ventilation

Secondary Measures

• duration of dependency on mechanical ventilation
• major bleeding
• heparin induced thrombocytopenia
• anti PF4/heparin antibodies

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 28 Days

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University Medicine Greifswald
• Overall Official(s)
  • Andreas Greinacher, MD, Study Chair, Institute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University Greifswald
  • Christoph Fusch, MD, Study Director, Pediatric Department, Ernst-Moritz-Arndt-University Greifswald
  • Anne F Klenner, MD, Principal Investigator, Medical Faculty, Ernst-Moritz-Arndt University Greifswald
• Overall Contact(s)
  • Andreas Greinacher, MD, greinach@uni-greifswald.de