NCT02076373

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_3

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

9.8 years

First QC Date

February 25, 2014

Last Update Submit

November 21, 2018

Conditions

Intraventricular Hemorrhage of Prematurity

Outcome Measures

Primary Outcomes (1)

  • Neurodevelopmental outcome

    With 5 years of age, composite intelligence quotient to be assessed by standardized IQ tests.

    5 years

Secondary Outcomes (5)

  • Biomarker cranial MRI

    40 weeks postmenstrual age

  • Safety

    Infants will be followed for the duration of hospital stay, an expected average of 14 weeks

  • Neurodevelopmental outcome

    2 years

  • Biomarker serial cranial ultrasound

    Infants will be followed for the duration of hospital stay, an expected average of 14 weeks

  • Overall developmental outcome

    5 years

Other Outcomes (1)

  • Course of intracerebral bleeding

    Infants will be followed for the duration of hospital stay, an expected average of 14 weeks

Study Arms (2)

recombinant human Erythropoietin (Epo)

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

recombinant human ErythropoietinDRUG

i.v. administration

Also known as: Epoetin beta
recombinant human Erythropoietin (Epo)
PlaceboDRUG

i.v. administration

Also known as: normal saline
Control

Eligibility Criteria

Age23 Weeks - 31 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Medical University of Vienna

Vienna, Austria

Location

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

University Children's Hospital Basel (UKBB)

Basel, 4031, Switzerland

Location

University Hospital Bern

Bern, 3010, Switzerland

Location

Kantonsspital Graubünden

Chur, 7000, Switzerland

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, 1011, Switzerland

Location

Ostschweizer Kinderspital

Sankt Gallen, 9006, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

  • Ruegger CM, Hagmann CF, Buhrer C, Held L, Bucher HU, Wellmann S; EpoRepair Investigators. Erythropoietin for the Repair of Cerebral Injury in Very Preterm Infants (EpoRepair). Neonatology. 2015;108(3):198-204. doi: 10.1159/000437248. Epub 2015 Aug 8.

    PMID: 26278911BACKGROUND

  • Wellmann S, Hagmann CF, von Felten S, Held L, Klebermass-Schrehof K, Truttmann AC, Knopfli C, Fauchere JC, Buhrer C, Bucher HU, Ruegger CM; Erythropoietin for the Repair of Cerebral Injury in Very Preterm Infants (EpoRepair) Investigators. Safety and Short-term Outcomes of High-Dose Erythropoietin in Preterm Infants With Intraventricular Hemorrhage: The EpoRepair Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244744. doi: 10.1001/jamanetworkopen.2022.44744.

    PMID: 36459138DERIVED

Related Links

MeSH Terms

Interventions

epoetin betaSaline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Sven Wellmann, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

  • Hans Ulrich Bucher, MD, PhD

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

March 3, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

CH(7)AU(1)