Erythropoietin Treatment in Extremely Low Birth Weight Infants

Anemia Clinical Trial

— EPO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593801
• Other study ID #: 12008
• Secondary ID: Hoffmann- La Roc
• Status: Completed
• Phase: N/A
• First received: January 4, 2008
• Last updated: January 4, 2008
• Start date: May 1998
• Est. completion date: June 1999

Study information

• Verified date: January 2008
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: June 1999
• Est. primary completion date: June 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Birth Weight
• Body Weight
• Infant, Low Birth Weight

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Dept of Neonatolgy Charité University Medicine Berlin	Berlin

Sponsors (13)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transfusion need		9 weeks	Yes
Secondary	concentrations of trace elements and antioxidant enzymes in the blood		9 weeks	No