Does Erythropoietin Improve Outcome in Very Preterm Infants? - Full Text View

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:

MedlinePlus related topics: Cerebral Palsy

Drug Information available for: Epoetin Alfa

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%

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Eligibility


Ages Eligible for Study:	up to 3 Hours (Child)
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

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:

Swiss Neonatal Network This link exits the ClinicalTrials.gov site

Publications:

Fauchère JC, Dame C, Vonthein R, Koller B, Arri S, Wolf M, Bucher HU. An approach to using recombinant erythropoietin for neuroprotection in very preterm infants. Pediatrics. 2008 Aug;122(2):375-82. doi: 10.1542/peds.2007-2591.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Natalucci G, Latal B, Koller B, Rüegger C, Sick B, Held L, Bucher HU, Fauchère JC; Swiss EPO Neuroprotection Trial Group. Effect of Early Prophylactic High-Dose Recombinant Human Erythropoietin in Very Preterm Infants on Neurodevelopmental Outcome at 2 Years: A Randomized Clinical Trial. JAMA. 2016 May 17;315(19):2079-85. doi: 10.1001/jama.2016.5504.

Fauchère JC, Koller BM, Tschopp A, Dame C, Ruegger C, Bucher HU; Swiss Erythropoietin Neuroprotection Trial Group. Safety of Early High-Dose Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants. J Pediatr. 2015 Jul;167(1):52-7.e1-3. doi: 10.1016/j.jpeds.2015.02.052. Epub 2015 Apr 8.

O'Gorman RL, Bucher HU, Held U, Koller BM, Hüppi PS, Hagmann CF; Swiss EPO Neuroprotection Trial Group. Tract-based spatial statistics to assess the neuroprotective effect of early erythropoietin on white matter development in preterm infants. Brain. 2015 Feb;138(Pt 2):388-97. doi: 10.1093/brain/awu363. Epub 2014 Dec 22.

Leuchter RH, Gui L, Poncet A, Hagmann C, Lodygensky GA, Martin E, Koller B, Darqué A, Bucher HU, Hüppi PS. Association between early administration of high-dose erythropoietin in preterm infants and brain MRI abnormality at term-equivalent age. JAMA. 2014 Aug 27;312(8):817-24. doi: 10.1001/jama.2014.9645.

Rüegger CM, Kraus A, Koller B, Natalucci G, Latal B, Waldesbühl E, Fauchère JC, Held L, Bucher HU. Randomized controlled trials in very preterm infants: does inclusion in the study result in any long-term benefit? Neonatology. 2014;106(2):114-9. doi: 10.1159/000362784. Epub 2014 Jun 20.


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:


Hemorrhage 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 Encephalomalacia Infant, Premature, Diseases Infant, Newborn, Diseases Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Epoetin Alfa Hematinics

ClinicalTrials.gov processed this record on September 26, 2016