We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    bucher epo
Previous Study | Return to List | Next Study

Does Erythropoietin Improve Outcome in Very Preterm Infants?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00413946
Recruitment Status : Completed
First Posted : December 20, 2006
Last Update Posted : October 30, 2018
Swiss National Science Foundation
Information provided by (Responsible Party):
Bucher Hans Ulrich, Swiss Neonatal Network

Brief Summary:

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

Show Show detailed description

Layout table for study information
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
Experimental: Erythropoietin
Three doses of rErythropoietin (3000 U/kg body weight) intravenously at 3, 12-18 and 36-42 hours after birth.
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
Drug: saline
three doses of 1.0 ml saline per body weight
Other Name: NaCl 0.9%

Primary Outcome Measures :
  1. Mental developmental index (Bayley II) and motor, visual and hearing impairment [ Time Frame: at age of 24 months corrected for prematurity. ]

Secondary Outcome Measures :
  1. MRI at term equivalent [ Time Frame: 40 postmenstrual weeks ]
    White matter injury score grey matter injury score brain maturation

  2. cerebral palsy. [ Time Frame: First 24 months of life (corrected for prematurity) ]
  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

Information from the National Library of Medicine

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

Layout table for location information
Aarau, Switzerland
Basel, Switzerland
Chur, Switzerland
Hopital universitaire
Geneva, Switzerland
University Hospital
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Neonatal Network
Swiss National Science Foundation
Layout table for investigator information
Principal Investigator: Hans U Bucher, Prof University of Zurich
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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
Keywords provided by Bucher Hans Ulrich, Swiss Neonatal Network:
Premature infant
developmental outcome
Additional relevant MeSH terms:
Layout table for MeSH terms
Epoetin Alfa
Cerebral Palsy
Intracranial Hemorrhages
Leukomalacia, Periventricular
Psychomotor Disorders
Pathologic Processes
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Neurobehavioral Manifestations
Neurologic Manifestations