NCT00196469

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

October 23, 2007

Status Verified

September 1, 2006

First QC Date

September 12, 2005

Last Update Submit

October 22, 2007

Conditions

Respiration, ArtificialHemorrhage

Outcome Measures

Primary Outcomes (1)

  • percentage of neonates requiring mechanical ventilation

Secondary Outcomes (4)

  • duration of dependency on mechanical ventilation

  • major bleeding

  • heparin induced thrombocytopenia

  • anti PF4/heparin antibodies

Interventions

heparinDRUG

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine

Greifswald, 17487, Germany

RECRUITING

MeSH Terms

Conditions

Respiratory AspirationHemorrhage

Interventions

Heparin

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Andreas Greinacher, MD

    Institute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University Greifswald

    STUDY CHAIR

  • Christoph Fusch, MD

    Pediatric Department, Ernst-Moritz-Arndt-University Greifswald

    STUDY DIRECTOR

  • Anne F Klenner, MD

    Medical Faculty, Ernst-Moritz-Arndt University Greifswald

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Greinacher, MD

CONTACT

greinach@uni-greifswald.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

December 1, 2003

Study Completion

March 1, 2007

Last Updated

October 23, 2007

Record last verified: 2006-09

Locations

DE(1)