NCT00593801

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 1998

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1998

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1999

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

Enrollment Period

1.1 years

First QC Date

January 4, 2008

Last Update Submit

January 4, 2008

Conditions

Infant, Low Birth WeightAnemia

Keywords

extremely low birth weight infantstransfusion neederythropoietintrace elementsantioxidant enzymesreduction of the transfusion need by EPO treatmenttrace elements and antioxidant enzymes in blood

Outcome Measures

Primary Outcomes (1)

  • transfusion need

    9 weeks

Secondary Outcomes (1)

  • concentrations of trace elements and antioxidant enzymes in the blood

    9 weeks

Study Arms (3)

2: late rhEPO

ACTIVE COMPARATOR

late EPO treatment from the fourth week for 6 weeks

Drug: epoetin beta

3: no EPO

NO INTERVENTION

control group, no EPO treatment

1: early rhEPO

ACTIVE COMPARATOR

early rhEPO treatment from the first week until 9 weeks

Drug: epoetin beta

Interventions

epoetin betaDRUG

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

1: early rhEPO

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Extremely low birth weight infants

You may not qualify if:

  • Cyanotic heart disease
  • Major congenital malformation requiring surgery
  • Gestational age \> 30 weeks
  • Administration of an investigational drug during pregnancy
  • Lack of parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Neonatolgy Charité University Medicine Berlin

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Anemia

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Michael Obladen, Prof.Dr.

    Charité Berlin, University Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 15, 2008

Study Start

May 1, 1998

Primary Completion

June 1, 1999

Study Completion

June 1, 1999

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

DE(1)