Does Erythropoietin Improve Outcome in Very Preterm Infants?
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ClinicalTrials.gov Identifier: NCT00413946 |
Recruitment Status :
Completed
First Posted : December 20, 2006
Last Update Posted : October 30, 2018
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The main goal of this trial is to investigate whether early administration of human erythropoietin (EPO) in very preterm infants improves neurodevelopmental outcome at 24 months corrected age.
This study is designed as randomized, double-masked, placebo controlled multicenter study involving at least 420 patients.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intracranial Hemorrhage Periventricular Leukomalacia Cerebral Palsy Developmental Psychomotor Disorders | Drug: Recombinant human Erythropoietin Drug: saline | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 420 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Neuroprotective Effect of High Dose Erythropoietin in Very Preterm Infants |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
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Experimental: Erythropoietin
Three doses of rErythropoietin (3000 U/kg body weight) intravenously at 3, 12-18 and 36-42 hours after birth.
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Drug: Recombinant human Erythropoietin
3 doses 3000 units (1 ml) of recombinant human erythropoietin per kg body weight |
Placebo Comparator: saline
Three doses of placebo (0.9% saline 1 ml/kg body weight) intravenously at 3, 12-18 and 36-42 hours after birth
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Drug: saline
three doses of 1.0 ml saline per body weight
Other Name: NaCl 0.9% |
- Mental developmental index (Bayley II) and motor, visual and hearing impairment [ Time Frame: at age of 24 months corrected for prematurity. ]
- MRI at term equivalent [ Time Frame: 40 postmenstrual weeks ]White matter injury score grey matter injury score brain maturation
- cerebral palsy. [ Time Frame: First 24 months of life (corrected for prematurity) ]
- Cognitive development and cerebral palsy [ Time Frame: 5 years ]
Kaufmann ABC II, standardized neurological, visual and hearing examination, questionnaire about health status and behavior.
Classification of impairments, disabilities and handicaps.

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Ages Eligible for Study: | up to 3 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Infants born between 26 0/7 and 31 6/7 gestational weeks
- Postnatal age less than 3 hours
- Informed parental consent (preferably obtained before birth)
Exclusion Criteria:
- Genetically defined syndrome
- Severe congenital malformation adversely affecting life expectancy
- Severe congenital malformation adversely affecting neurodevelopment
- A priory palliative care
- Intracranial haemorrhage grade 3 or more detected before dose 3 of Erythropoietin

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413946
Switzerland | |
Kantonsspital | |
Aarau, Switzerland | |
Kantonsspital | |
Basel, Switzerland | |
Kantonsspital | |
Chur, Switzerland | |
Hopital universitaire | |
Geneva, Switzerland | |
University Hospital | |
Zurich, Switzerland, CH-8091 |
Principal Investigator: | Hans U Bucher, Prof | University of Zurich |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bucher Hans Ulrich, full professor of Neonatology, Swiss Neonatal Network |
ClinicalTrials.gov Identifier: | NCT00413946 |
Other Study ID Numbers: |
3200B0-108176 RoFAR ID 2127989593 ( Other Grant/Funding Number: 3200B0-108176 ) 3200B0-108176 ( Other Grant/Funding Number: SNF 3200B0-108176 ) |
First Posted: | December 20, 2006 Key Record Dates |
Last Update Posted: | October 30, 2018 |
Last Verified: | October 2018 |
Premature infant developmental outcome |
Cerebral Palsy Intracranial Hemorrhages Leukomalacia, Periventricular Psychomotor Disorders Hemorrhage Pathologic Processes Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Encephalomalacia Infant, Premature, Diseases Infant, Newborn, Diseases Neurobehavioral Manifestations Neurologic Manifestations Epoetin Alfa Hematinics |