Erythropoietin Treatment in Extremely Low Birth Weight Infants
NCT ID: NCT00593801
Last Updated: 2008-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
219 participants
INTERVENTIONAL
1998-05-31
1999-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too.
Study population: 219 patient randomized into 3 groups
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants
NCT01203514
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
NCT00589953
Erythropoietin in Premature Infants to Prevent Encephalopathy
NCT02550054
Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
NCT01235923
Optimized Erythropoietin (EPO) Treatment
NCT02075970
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. Clinical and nutritional data were recorded prospectively.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
2: late rhEPO
late EPO treatment from the fourth week for 6 weeks
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
3: no EPO
control group, no EPO treatment
No interventions assigned to this group
1: early rhEPO
early rhEPO treatment from the first week until 9 weeks
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Major congenital malformation requiring surgery
* Gestational age \> 30 weeks
* Administration of an investigational drug during pregnancy
* Lack of parental consent
1 Day
3 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
University Hospital Tuebingen
OTHER
Children's Hospital at the Bult Hannover, Germany
UNKNOWN
University Hospital, Aachen
OTHER
University of Zurich
OTHER
Children's Hospital Koeln, Germany
UNKNOWN
Université Catholique de Louvain
OTHER
Children's Hospital Dortmund, Germany
UNKNOWN
Hopital Antoine Beclere
OTHER
Hôpital Edouard Herriot
OTHER
Olga Hospital Stuttgart, Germany
UNKNOWN
University Hospital, Strasbourg, France
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University Medicine Berlin, Charité
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Obladen, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Charité Berlin, University Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dept of Neonatolgy Charité University Medicine Berlin
Berlin, State of Berlin, Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Hoffmann- La Roche,MF 4481
Identifier Type: -
Identifier Source: secondary_id
12008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.