Does Erythropoietin Improve Outcome in Very Preterm Infants?
|ClinicalTrials.gov Identifier: NCT00413946|
Recruitment Status : Completed
First Posted : December 20, 2006
Last Update Posted : February 25, 2015
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 Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Neuroprotective Effect of High Dose Erythropoietin in Very Preterm Infants|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
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%
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413946
|Zurich, Switzerland, CH-8091|
|Principal Investigator:||Hans U Bucher, Prof||University of Zurich|