Infant, Low Birth WeightEPONCT00593801
Erythropoietin Treatment in Extremely Low Birth Weight Infants
A study testing epoetin beta in people with Infant, Low Birth Weight and Anemia, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Infant, Low Birth Weight, Anemia
- What is being tested?
- epoetin beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteGermany
- Study dates
- May 1998to Jun 1999
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Extremely low birth weight infants
Who cannot join
- Cyanotic heart disease
- Major congenital malformation requiring surgery
- Gestational age > 30 weeks
- Administration of an investigational drug during pregnancy
- Lack of parental consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept of Neonatolgy Charité University Medicine Berlin
Berlin, State of Berlin, 13353
About this study
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
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
Read the 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.
- Conditions
- Infant, Low Birth Weight, Anemia
- Being tested
- epoetin beta
- 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
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
epoetin betaDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 2: late rhEPO | Active comparator | late EPO treatment from the fourth week for 6 weeks Receives: 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 Receives: Drug: epoetin beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
transfusion need
Measured: 9 weeks
Secondary outcomes (1)
concentrations of trace elements and antioxidant enzymes in the blood
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startMay 1998
- Primary completionJun 1999
- Study completionJun 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Low Birth WeightStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Michael Obladen, Prof.Dr., Principal investigator, Charité Berlin, University Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593801
- Sponsor's protocol ID
- 12008
- Other IDs
- Hoffmann- La Roche,MF 4481
- Acronym
- EPO
- Status last verified
- Jan 2008
- First submitted
- 4 Jan 2008
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00593801
- Acronym / sponsor ID
- EPO / 12008
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- 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
- Study start
- May 1998
- Primary completion
- Jun 1999 (actual)
- Study completion
- Jun 1999 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2: late rhEPO | Active comparator | Drug: epoetin betalate EPO treatment from the fourth week for 6 weeks |
| 3: no EPO | No intervention | –control group, no EPO treatment |
| 1: early rhEPO | Active comparator | Drug: epoetin betaearly rhEPO treatment from the first week until 9 weeks |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Extremely low birth weight infants
Key exclusion criteria (5 listed)
- Cyanotic heart disease
- Major congenital malformation requiring surgery
- Gestational age > 30 weeks
- Administration of an investigational drug during pregnancy
- Lack of parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epoetin beta250 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 | Drug | 1: early rhEPO |
| epoetin beta250 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 | Drug | 2: late rhEPO |
Primary outcome
transfusion need
Time frame: 9 weeks
1 secondary outcome
concentrations of trace elements and antioxidant enzymes in the blood
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2008.
Related trials for Infant, Low Birth Weight
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Not yet recruitingPhase 1
Breast-milk Enema Administration to Stimulate Passage of Meconium
Breast-milk
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Obladen, Prof.Dr. principal investigator
Charité Berlin, University Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epoetin beta in people with Infant, Low Birth Weight and Anemia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transfusion need (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2008.