Does Erythropoietin Improve Outcome in Very Preterm Infants?
This study has been completed.
Sponsor:
Swiss Neonatal Network
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Bucher Hans Ulrich, Swiss Neonatal Network
ClinicalTrials.gov Identifier:
NCT00413946
First received: December 18, 2006
Last updated: February 23, 2015
Last verified: February 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Intracranial Hemorrhage Periventricular Leukomalacia Cerebral Palsy Developmental Psychomotor Disorders |
Drug: Recombinant human Erythropoietin Drug: saline |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Neuroprotective Effect of High Dose Erythropoietin in Very Preterm Infants |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Cerebral Palsy
Leukomalacia
Periventricular Leukomalacia
U.S. FDA Resources
Further study details as provided by Swiss Neonatal Network:
Primary Outcome Measures:
- Mental developmental index (Bayley II) and motor, visual and hearing impairment [ Time Frame: at age of 24 months corrected for prematurity. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- MRI at term equivalent [ Time Frame: 40 postmenstrual weeks ] [ Designated as safety issue: No ]White matter injury score grey matter injury score brain maturation
- cerebral palsy. [ Time Frame: First 24 months of life (corrected for prematurity) ] [ Designated as safety issue: No ]
- Cognitive development and cerebral palsy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Kaufmann ABC II, standardized neurological, visual and hearing examination, questionnaire about health status and behavior.
Classification of impairments, disabilities and handicaps.
| Enrollment: | 420 |
| Study Start Date: | January 2006 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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%
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 3 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413946
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413946
Locations
| Switzerland | |
| Kantonsspital | |
| Aarau, Switzerland | |
| Kantonsspital | |
| Basel, Switzerland | |
| Kantonsspital | |
| Chur, Switzerland | |
| Hopital universitaire | |
| Geneva, Switzerland | |
| University Hospital | |
| Zurich, Switzerland, CH-8091 | |
Sponsors and Collaborators
Swiss Neonatal Network
Swiss National Science Foundation
Investigators
| Principal Investigator: | Hans U Bucher, Prof | University of Zurich |
More Information
Additional Information:
Publications:
Additional 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 History of Changes |
| Other Study ID Numbers: | 3200B0-108176, RoFAR ID 2127989593, 3200B0-108176 |
| Study First Received: | December 18, 2006 |
| Last Updated: | February 23, 2015 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Swiss Neonatal Network:
|
Premature infant developmental outcome |
Additional relevant MeSH terms:
|
Intracranial Hemorrhages Leukomalacia, Periventricular Psychomotor Disorders Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Encephalomalacia Hemorrhage Infant, Newborn, Diseases Infant, Premature, Diseases |
Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Signs and Symptoms Vascular Diseases Epoetin alfa Hematinics Hematologic Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015