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Erythropoietin Treatment in Extremely Low Birth Weight Infants (EPO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593801
First Posted: January 15, 2008
Last Update Posted: January 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hoffmann-La Roche
University Hospital Tuebingen
Children's Hospital at the Bult Hannover, Germany
University Hospital, Aachen
University of Zurich
Children's Hospital Koeln, Germany
Université Catholique de Louvain
Children's Hospital Dortmund, Germany
Hopital Antoine Beclere
Hôpital Edouard Herriot
Olga Hospital Stuttgart, Germany
University Hospital, Strasbourg, France
Information provided by:
Charite University, Berlin, Germany
  Purpose

Objective: To investigate whether recombinant EPO reduces the need for transfusion in extremely low birth weight (ELBW) infants and to determine the optimal time for treatment.

The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too.

Study population: 219 patient randomized into 3 groups


Condition Intervention
Infant, Low Birth Weight Anemia Drug: epoetin beta

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre, Blinded, Randomised, Controlled Study on the Efficacy and Safety of Early or Late Epoetin Beta Treatment in Premature Infants (500- 999g Birth Weight)for Prevention or Treatment of Anaemia of Prematurity

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • transfusion need [ Time Frame: 9 weeks ]

Secondary Outcome Measures:
  • concentrations of trace elements and antioxidant enzymes in the blood [ Time Frame: 9 weeks ]

Enrollment: 219
Study Start Date: May 1998
Study Completion Date: June 1999
Primary Completion Date: June 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2: late rhEPO
late EPO treatment from the fourth week for 6 weeks
Drug: epoetin beta
250 IU/kg/week subcutaneously 3 times a week, from the fourth week for 6 weeks, all infants received enteral iron 3-9 mg/kg/day
No Intervention: 3: no EPO
control group, no EPO treatment
Active Comparator: 1: early rhEPO
early rhEPO treatment from the first week until 9 weeks
Drug: epoetin beta
250 IU/kg/week rhEPO treatment subcutaneously 3 times a week from the first week for 9 weeks, all infants received enteral iron 3-9 mg/kg/day

Detailed Description:

Methods: Blinded , multicenter trial, ELBW infants were randomized on day 3 to one of 3 groups: early EPO group (rhEPO from the first week for 9 weeks , n= 74), late rhEPO group (rhWEPO from the fourth week for 6 weeks, n=74), or control group (no rhEPO, n= 71). All infants received enteral iron (3-9 mg/kg/day) from the first week. The rhEPO ß dose was 750 IU/kg/week. Success was defined as no transfusion and hematocrit levels never below 30%.

The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. Clinical and nutritional data were recorded prospectively.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Extremely low birth weight infants

Exclusion Criteria:

  • Cyanotic heart disease
  • Major congenital malformation requiring surgery
  • Gestational age > 30 weeks
  • Administration of an investigational drug during pregnancy
  • Lack of parental consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593801


Locations
Germany
Dept of Neonatolgy Charité University Medicine Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Hoffmann-La Roche
University Hospital Tuebingen
Children's Hospital at the Bult Hannover, Germany
University Hospital, Aachen
University of Zurich
Children's Hospital Koeln, Germany
Université Catholique de Louvain
Children's Hospital Dortmund, Germany
Hopital Antoine Beclere
Hôpital Edouard Herriot
Olga Hospital Stuttgart, Germany
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Michael Obladen, Prof.Dr. Charité Berlin, University Medicine
  More Information

Responsible Party: Prof. Dr. Michael Obladen, former Head of the Dpt. of Neonatology Charité Berlin, University Medicine Berlin, Charité
ClinicalTrials.gov Identifier: NCT00593801     History of Changes
Other Study ID Numbers: 12008
Hoffmann- La Roche,MF 4481
First Submitted: January 4, 2008
First Posted: January 15, 2008
Last Update Posted: January 15, 2008
Last Verified: January 2008

Keywords provided by Charite University, Berlin, Germany:
extremely low birth weight infants
transfusion need
erythropoietin
trace elements
antioxidant enzymes
reduction of the transfusion need by EPO treatment
trace elements and antioxidant enzymes in blood

Additional relevant MeSH terms:
Body Weight
Anemia
Birth Weight
Signs and Symptoms
Hematologic Diseases
Epoetin Alfa
Antioxidants
Trace Elements
Hematinics
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances