Erythropoietin for the repair of cerebral injury in very preterm infants, a randomized, double-blind, placebo-controlled, prospective, and multicenter clinical study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000612-34-AT

Enrollment

120

Registered

2015-10-16

Start date

2015-12-15

Completion date

Unknown

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1 out of 100 children born extremely early, or more than 8 weeks before the expected date. 20% of these extremely preterm children shows a cerebral hemorrhage at birth, leading to a significantly increased risk for neurodevelopmental deficits through to cerebral palsy. Recombinant erythropoietin is approved as a drug for the prevention of anemia of prematurity. Retrospective analyzes of Epo-treated preterm infants show improved neurological development in children after cerebral hemorrhage.

Interventions

Trade Name: NeoRecormon 2000 ® 2.000/I.E. Injektionslösung in Fertigspritze Pharmaceutical Form: Solution and suspension for suspension for injection in pre-filled syringe INN or Proposed INN: EPOETIN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Informed written parental consent - IVH (grade II-IV) - GA =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Genetically defined syndrome - Severe congenital malformation adversely affecting life expectancy or neurodevelopment - Admitted a priori for palliative care - Unlikely to participate at 5-year follow-up examination - Lack of willingness to storage and disclosure of pseudonymous disease data in the context of the clinical trial; - patients enrolled in this EPO-repair study are not allowed to receive EPO for other purposes;

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective: At 5 years of age: Intelligence quotient (Kaufman Assessment Battery for Children, german version (K-ABC);Secondary Objective: Secondary objectives: 1) cerebral ultrasound (cUS) findings until discharge 2) At term equivalent age: Brain injury score assessed on brain MRI 3) At 24 months: Mental development (Bayley III), incidence of visual, hearing and motor impairment;Primary end point(s): At 5 years of age: Intelligence quotient (Kaufman Assessment Battery for Children, german version (K-ABC);Timepoint(s) of evaluation of this end point: At 5 years of age	—

Measure

Time frame

Main Objective: Primary objective: At 5 years of age: Intelligence quotient (Kaufman Assessment Battery for Children, german version (K-ABC);Secondary Objective: Secondary objectives: 1) cerebral ultrasound (cUS) findings until discharge 2) At term equivalent age: Brain injury score assessed on brain MRI 3) At 24 months: Mental development (Bayley III), incidence of visual, hearing and motor impairment;Primary end point(s): At 5 years of age: Intelligence quotient (Kaufman Assessment Battery for Children, german version (K-ABC);Timepoint(s) of evaluation of this end point: At 5 years of age

—

Secondary

Measure	Time frame
Secondary end point(s): 1) cerebral ultrasound (cUS) findings until discharge 2) At term equivalent age: Brain injury score assessed on brain MRI 3) At 24 months: Mental development (Bayley III), incidence of visual, hearing and motor impairment;Timepoint(s) of evaluation of this end point: ad 1) At term equivalent age ad 2) At term equivalent age ad 3) At 24 months	—

Countries

Austria, Switzerland

Contacts

Public ContactPD Dr. Sven Wellmann, Neonatologie

UniversitätsSpital Zürich

sven.wellmann@usz.ch41442555340

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Apr 23, 2026