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

Active, not recruiting

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.
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-000612-34-AT

Lead Sponsor: niversitätsSpital Zürich

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

Inclusion Criteria

- Informed written parental consent
- IVH (grade II-IV)
- GA < 32 0/7 weeks and/or BW < 1’500 g at birth. (Comment: There is a steep rise in the incidence of IVH with decreasing GA and decreasing BW)
?- Chronological age < 8 d. (Comment: More than 96% of all cases of IVH happen within the first 5 d of life. In contrast, IVH in term infants is a rare event and follows a rather different clinical course.)
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective: At 5 years of age: Intelligence quotient (Kaufman Assessment Battery for Children, german version (K-ABC);Secondary Objective: Secondary objectives:<br>1) cerebral ultrasound (cUS) findings until discharge<br>2) At term equivalent age: Brain injury score assessed on brain MRI<br>3) At 24 months: Mental development (Bayley III), incidence of visual,<br>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 Outcome Measures

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