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Erythropoietin Treatment in Extremely Low Birth Weight Infants (EPO)

Primary Purpose

Infant, Low Birth Weight, Anemia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
epoetin beta
epoetin beta
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Low Birth Weight focused on measuring 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

Eligibility Criteria

1 Day - 3 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of Neonatolgy Charité University Medicine Berlin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Active Comparator

Arm Label

2: late rhEPO

3: no EPO

1: early rhEPO

Arm Description

late EPO treatment from the fourth week for 6 weeks

control group, no EPO treatment

early rhEPO treatment from the first week until 9 weeks

Outcomes

Primary Outcome Measures

transfusion need

Secondary Outcome Measures

concentrations of trace elements and antioxidant enzymes in the blood

Full Information

First Posted
January 4, 2008
Last Updated
January 4, 2008
Sponsor
Charite University, Berlin, Germany
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
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1. Study Identification

Unique Protocol Identification Number
NCT00593801
Brief Title
Erythropoietin Treatment in Extremely Low Birth Weight Infants
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
June 1999 (Actual)
Study Completion Date
June 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Low Birth Weight, Anemia
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2: late rhEPO
Arm Type
Active Comparator
Arm Description
late EPO treatment from the fourth week for 6 weeks
Arm Title
3: no EPO
Arm Type
No Intervention
Arm Description
control group, no EPO treatment
Arm Title
1: early rhEPO
Arm Type
Active Comparator
Arm Description
early rhEPO treatment from the first week until 9 weeks
Intervention Type
Drug
Intervention Name(s)
epoetin beta
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
epoetin beta
Intervention Description
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
Primary Outcome Measure Information:
Title
transfusion need
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
concentrations of trace elements and antioxidant enzymes in the blood
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Obladen, Prof.Dr.
Organizational Affiliation
Charité Berlin, University Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Neonatolgy Charité University Medicine Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

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Erythropoietin Treatment in Extremely Low Birth Weight Infants

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