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Erythropoietin for the Repair of Cerebral Injury in Very Preterm Infants (EpoRepair)

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ClinicalTrials.gov Identifier: NCT02076373
Recruitment Status : Active, not recruiting
First Posted : March 3, 2014
Last Update Posted : November 22, 2018
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
The purpose of this randomized and placebo-controlled EpoRepair trial is to evaluate the effect of intravenously administered recombinant human erythropoietin (Epo) as compared to placebo in preterm infants with brain damage on neurological development until five years od age.

Condition or disease Intervention/treatment Phase
Intraventricular Hemorrhage of Prematurity Drug: recombinant human Erythropoietin Drug: Placebo Phase 3

Detailed Description:

Worldwide, 1% of all infants are born very preterm with less than 32 weeks of gestation, which is more than 2 months before expected date of delivery. If these smallest infants suffer in addition to prematurity a second hit, such as intraventricular hemorrhage or parenchymal infarction, they are at high risk for learning disabilities, mental retardation, and cerebral palsy in later life.

Intraventricular hemorrhage and parenchymal infarction occur in about 12% of very preterm infants, mostly in the very smallest and within the first few days after birth, and can be recorded by cranial ultrasound. Except for shunt insertion to divert cerebrospinal fluid in infants with posthemorrhagic hydrocephalus and possibly the removal of blood clots, there is no treatment for established intracerebral bleeding, and no medical therapies exist to ameliorate the neurodevelopmental sequelae.

Apart from stimulating production of red blood cells in the bone marrow, recombinant human erythropoietin (Epo) has been shown to exert neuroprotective action in a variety of animal models and in clinical studies. Epo administration has been found to be beneficial and safe in randomized controlled trials (RCT) involving adult and infant patients.

Observational data suggest that Epo administered to very preterm infants in order to prevent from anemia improves long-term cognitive outcomes until school-age especially in those infants who had suffered intracerebral bleeding. These data, however, are observational and therefore do not allow for any firm conclusions or recommendations. The hypothesis generated by these data calls for confirmation or refutation by an RCT designed to address this question.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erythropoietin for the Repair of Cerebral Injury in Very Preterm Infants - a Randomized, Double-blind, Placebo-controlled, Prospective, and Multicenter Clinical Study
Study Start Date : March 2014
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: recombinant human Erythropoietin (Epo)

Epo 2000 U in normal saline per ml/kg of body weight 5 times intravenously, total dosage 10000 U per 5ml/kg.

In detail: For loading 3 times beginning at day 5 of life (± 2 days), followed at 24 hours and 48 hours later. For maintenance 2 times, at day 10 and day 17 after the first study medication.

Drug: recombinant human Erythropoietin
i.v. administration
Other Name: Epoetin beta

Placebo Comparator: Control

Placebo 1 ml normal saline/kg of body weight 5 times intravenously, total dosage 5 ml/kg.

In detail: For loading 3 times beginning at day 5 of life (± 2 days), followed at 24 hours and 48 hours later. For maintenance 2 times, at day 10 and day 17 after the first study medication.

Drug: Placebo
i.v. administration
Other Name: normal saline




Primary Outcome Measures :
  1. Neurodevelopmental outcome [ Time Frame: 5 years ]
    With 5 years of age, composite intelligence quotient to be assessed by standardized IQ tests.


Secondary Outcome Measures :
  1. Biomarker cranial MRI [ Time Frame: 40 weeks postmenstrual age ]
    Brain injury score assessed on cranial MRI, including brain maturation score and white matter and gray matter injury scores, as biomarker for long-term neurodevelopmental outcome.

  2. Safety [ Time Frame: Infants will be followed for the duration of hospital stay, an expected average of 14 weeks ]
    Analysis will be performed to get insight about the distributions of adverse events and other safety relevant outcomes between groups.

  3. Neurodevelopmental outcome [ Time Frame: 2 years ]
    Bayley Scales of Infant Development (BSID-III) and the presence or absence of impairment of motor function (cerebral palsy) and neurosensory function (blindness or deafness) will be assessed with 18 to 24 months.

  4. Biomarker serial cranial ultrasound [ Time Frame: Infants will be followed for the duration of hospital stay, an expected average of 14 weeks ]
    Cranial ultrasound is a useful point of care method to detect, confirm and monitor brain damage including intracerebral bleeding. It is part of clinical routine for the duration of hospital stay.

  5. Overall developmental outcome [ Time Frame: 5 years ]
    Neurological and formal psychological examination. Normal Overall developmental outcome is classified as normal if IQ >84 and without one or more of the following: motor impairment, cognitive impairment, behavior problems, poor general health, severe hearing loss, or bilateral blindness.


Other Outcome Measures:
  1. Course of intracerebral bleeding [ Time Frame: Infants will be followed for the duration of hospital stay, an expected average of 14 weeks ]

    Course of intracerebral bleeding from onset until term equivalent age with additional visits at 28 days of life and 36 weeks postmenstrual age.

    1. No remaining lesions as recorded by cranial ultrasound
    2. Persisting posthemorrhagic hydrocephalus without any drainage
    3. Persisting posthemorrhagic hydrocephalus with repetitive but transient csf-drainage
    4. Posthemorrhagic hydrocephalus with permanent csf-drainage
    5. Convulsions and other abnormalities or medications related to intracerebral bleeding



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 31 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants with less than 32 weeks of gestation and/or less than 1500 g weight at birth
  2. Intraventricular hemorrhage and/or hemorrhagic parenchymal infarction
  3. Less than 8 days of life
  4. Informed written parental consent

Exclusion Criteria:

  1. Genetically defined syndrome
  2. Severe congenital malformation adversely affecting life expectancy and/or neurodevelopment
  3. A priory palliative care
  4. Unlikely to participate at 5-year follow-up examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076373


Locations
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Austria
Medical University of Vienna
Vienna, Austria
Switzerland
Kantonsspital Aarau
Aarau, Switzerland, 5001
University Children's Hospital Basel (UKBB)
Basel, Switzerland, 4031
University Hospital Bern
Bern, Switzerland, 3010
Kantonsspital Graubünden
Chur, Switzerland, 7000
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
Ostschweizer Kinderspital
St. Gallen, Switzerland, 9006
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
Investigators
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Principal Investigator: Sven Wellmann, MD University of Zurich
Study Chair: Hans Ulrich Bucher, MD, PhD University of Zurich

Additional Information:
Publications:
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02076373     History of Changes
Other Study ID Numbers: EpoRepair
2013DR3204 ( Other Identifier: Swissmedic )
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Hemorrhage
Cerebral Hemorrhage
Brain Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Epoetin Alfa
Hematinics