Erythropoietin Treatment in Extremely Low Birth Weight Infants (EPO)

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00593801
First received: January 4, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • concentrations of trace elements and antioxidant enzymes in the blood [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 4, 2008
Last Updated: January 4, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

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:
Anemia
Birth Weight
Body Weight
Hematologic Diseases
Signs and Symptoms
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014