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Completed

NCT Number: NCT00593801

Erythropoietin Treatment in Extremely Low Birth Weight Infants

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

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Key information

Conditions

Infant, Low Birth Weight Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Neonatolgy Charité University Medicine Berlin

Berlin, State of Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epoetin beta

Drug

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

Primary outcomes

  1. transfusion need

    Time frame: 9 weeks

Secondary outcomes

  1. concentrations of trace elements and antioxidant enzymes in the blood

    Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Children's Hospital Dortmund, Germany
  • Children's Hospital Koeln, Germany
  • Children's Hospital at the Bult Hannover, Germany
  • Hoffmann-La Roche
  • Hopital Antoine Beclere
  • Hôpital Edouard Herriot
  • Olga Hospital Stuttgart, Germany
  • University Hospital Tuebingen
  • University Hospital, Aachen
  • University Hospital, Strasbourg, France
  • University of Zurich
  • Université Catholique de Louvain

Registry information

Official study 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

Acronym: EPO

Important dates

Study start
1998
Primary completion
1999
Study completion
1999
First posted
Jan 15, 2008
Registry last updated
Jan 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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