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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

January 4, 2008
January 4, 2008
May 1998
June 1999   (final data collection date for primary outcome measure)
transfusion need [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
concentrations of trace elements and antioxidant enzymes in the blood [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Erythropoietin Treatment in Extremely Low Birth Weight Infants
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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Infant, Low Birth Weight
  • Anemia
  • 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
  • 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
  • Active Comparator: 2: late rhEPO
    late EPO treatment from the fourth week for 6 weeks
    Intervention: Drug: epoetin beta
  • 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
    Intervention: Drug: epoetin beta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
219
June 1999
June 1999   (final data collection date for primary outcome measure)

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
Both
up to 3 Days
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00593801
12008, Hoffmann- La Roche,MF 4481
Yes
Prof. Dr. Michael Obladen, former Head of the Dpt. of Neonatology Charité Berlin, University Medicine Berlin, Charité
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
Principal Investigator: Michael Obladen, Prof.Dr. Charité Berlin, University Medicine
Charite University, Berlin, Germany
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP