Does Erythropoietin Improve Outcome in Very Preterm Infants?
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.
|Intracranial Hemorrhage Periventricular Leukomalacia Cerebral Palsy Developmental Psychomotor Disorders||Drug: Recombinant human Erythropoietin Drug: saline||Phase 2|
|Study Design:||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|
- 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.
|Study Start Date:||January 2006|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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
three doses of 1.0 ml saline per body weight
Other Name: NaCl 0.9%
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00413946
|Zurich, Switzerland, CH-8091|
|Principal Investigator:||Hans U Bucher, Prof||University of Zurich|