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Sponsors and Collaborators: |
Swiss Neonatal Network Swiss National Science Foundation |
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Information provided by: | Swiss Neonatal Network |
ClinicalTrials.gov Identifier: | NCT00413946 |
HYPOTHESIS Early administration of human erythropoietin (EPO) in very preterm infants reduces perinatal injury to the brain (retina), lung and gut and improves neurodevelopmental outcome at 24 months corrected age.
PRIMARY OBJECTIVE To determine whether cerebral outcome is improved if infants born between 24 0/7 and 31 6/7 gestational weeks at birth receive erythropoietin in high dose in the first three days after birth.
SECONDARY OBJECTIVES To determine whether early administration of EPO alters the incidence of complications typically associated with preterm birth, i.e. mortality, septicaemia, necrotising enterocolitis, bronchopulmonary dysplasia (oxygen dependency at 36 weeks postmenstrual age), retinopathy, intracranial haemorrhage, white matter disease (periventricular leucomalacia), growth failure, cerebral palsy and handicap at 5 years.
RATIONALE EPO has been shown to be protective against hypoxic-ischaemic and inflammatory injuries in a broad range of tissues and organs besides promoting red cell formation. It has been shown to have neuroprotective and neurotrophic activity in animals after acute brain damage as well as in adult stroke patients.
Several mechanisms explaining this activity have been recognized: EPO inhibits glutamate release in the brain, modulates intracellular calcium metabolism, induces the generation of anti-apoptotic factors, reduces inflammation, decreases nitric oxide–mediated injury, and has direct antioxidant effects. Very preterm infants have significant delay in mental and physical development assessed at 24 months corrected age. The most critical period are the first days after preterm birth where the oxygenation of the brain may be impaired by respiratory, circulatory and nutritional insufficiency. Although there are probably several mechanisms involved in permanent brain damage, it is most likely that EPO with its multiple action may reduce this damage.
EPO has been studied in several trials in preterm infants to prevent anaemia and is now widely used for this indication.
STUDY DESIGN Randomized, double-masked, placebo-controlled multi-center clinical trial. Research plan 420 infants will be randomized during the first three hours of life to receive EPO (3000 U/kg body weight) or placebo intravenously at 3, 12-18 and 36-42 hours after birth. Standardized evaluation including cerebral sonography at day 1 and 7 and at 36 0/7 gestational weeks (or at discharge home if discharged before) will determine the presence or absence of complications. Cerebral volume and white matter volume will be assessed at 40 postmenstrual weeks with MRI (only if available). Experienced examiners will assess developmental function at 24 months corrected age using the reliable and validly revised Bayley Scales II of Infant Development and determine the presence or absence of impairment of motor function (cerebral palsy) and neurosensory function (blindness or deafness).
CLINICAL SIGNIFICANCE At least 1 of every 100 liveborn infants is born very preterm. 90% of these infants survive but >50% have a delay in mental and physical development assessed at 24 months corrected age. More subtle problems affecting cognition, vision and hearing are common at the age of five years and have an impact on school performance and quality of life of the infants and their families. The aim of this trial is to examine whether a short, easily applicable and well tolerated pharmacological intervention can improve neurodevelopmental outcome.
Condition | Intervention | Phase |
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Intracranial Hemorrhage Periventricular Leukomalacia Postnatal Development Cerebral Palsy |
Drug: Recombinant human Erythropoietin |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Bio-availability Study |
Official Title: | Neuroprotective Effect of High Dose Eryhtropoietin in Very Preterm Infants |
Estimated Enrollment: | 420 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | May 2011 |
Ages Eligible for Study: | up to 3 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hans U Bucher, Prof | +41 (0)44 255 53 40 | buh@usz.ch |
Contact: Brigitte M Koller, study nurse | BrigitteMaria.koller@usz.ch |
Switzerland | |
University Hospital | Recruiting |
Zurich, Switzerland, CH-8091 | |
Contact: Hans U Bucher, Prof +41-44-255 53 40 buh@usz.ch | |
Contact: Jean-Claude Fauchere, MD +41-44-255 53 40 jean-claude.fauchere@usz.ch | |
Principal Investigator: Jean-Claude Fauchere, MD | |
Kantonsspital | Recruiting |
Basel, Switzerland | |
Contact: Bührer Christoph, Prof. | |
Principal Investigator: Christoph Bührer, Prof. | |
Kantonsspital | Recruiting |
Aarau, Switzerland | |
Contact: Georg Zeilinger, MD georg.zeilinger@ksa.ch | |
Contact: Sylvaine Pasquier, MD sylvaine.pasquier@ksa.ch | |
Principal Investigator: Georg Zeilinger, MD | |
Abteilung für Neonatologie, Inselspital | Not yet recruiting |
Berne, Switzerland | |
Contact: Mathias Nelle, PD | |
Principal Investigator: Mathias Nelle, PD | |
Hopital universitaire | Recruiting |
Geneva, Switzerland | |
Contact: Riccardo Pfister, MD | |
Principal Investigator: Riccardo Pfister, MD | |
Principal Investigator: Petra S Hueppi, Prof | |
Kantonsspital | Recruiting |
Chur, Switzerland | |
Contact: Brigitte Scharrer, MD brigitte.scharrer@ksg.ch | |
Principal Investigator: Brigitte Scharrer, MD |
Principal Investigator: | Hans U Bucher, Prof | University of Zurich |
Study ID Numbers: | 3200B0-108176, RoFAR ID 2127989593 |
Study First Received: | December 18, 2006 |
Last Updated: | April 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00413946 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Premature infant developmental outcome |
Epoetin Alfa Hematinics Brain Damage, Chronic Vascular Diseases Central Nervous System Diseases Infant, Premature, Diseases Intracranial Hemorrhages Periventricular Leukomalacia Hemorrhage |
Brain Diseases Cerebrovascular Disorders Leukomalacia, Periventricular Paralysis Cerebral Palsy Encephalomalacia Leukomalacia Infant, Newborn, Diseases Brain Injuries |
Epoetin Alfa Hematinics Hematologic Agents Brain Damage, Chronic Nervous System Diseases Vascular Diseases Central Nervous System Diseases Infant, Premature, Diseases Intracranial Hemorrhages Hemorrhage |
Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Leukomalacia, Periventricular Cerebral Palsy Pathologic Processes Encephalomalacia Therapeutic Uses Infant, Newborn, Diseases Cardiovascular Diseases |