Clinical Trial: Does Erythropoietin Improve Outcome in Very Preterm Infants?

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Neuroprotective Effect of High Dose Erythropoietin in Very Preterm Infants

Brief Summary:

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.


Detailed Summary:

HYPOTHESIS Early administration of human erythropoietin (EPO) in very preterm infants reduces perinatal injury to the brain (retina), lung and gut and improves neurodevelopmental outcome at 24 months corrected age.

PRIMARY OBJECTIVE To determine whether cerebral outcome is improved if infants born between 26 0/7 and 31 6/7 gestational weeks at birth receive erythropoietin in high dose in the first three days after birth.

SECONDARY OBJECTIVES To determine whether early administration of EPO alters the incidence of complications typically associated with preterm birth, i.e. mortality, septicaemia, necrotising enterocolitis, bronchopulmonary dysplasia (oxygen dependency at 36 weeks postmenstrual age), retinopathy, intracranial haemorrhage, white matter disease (periventricular leucomalacia), growth failure, cerebral palsy and handicap at 5 years.

Biomarkers of encephalopathy of prematurity assessed on magnetic resonance imaging (MRI) at term equivalent age.

RATIONALE EPO has been shown to be protective against hypoxic-ischaemic and inflammatory injuries in a broad range of tissues and organs besides promoting red cell formation. It has been shown to have neuroprotective and neurotrophic activity in animals after acute brain damage as well as in adult stroke patients. Several mechanisms explaining this activity have been recognized: EPO inhibits glutamate release in the brain, modulates intracellular calcium metabolism, induces the generation of anti-apoptotic factors, reduces inflammation, decreases nitric oxide-mediated injury, and has direct antioxidant effects.

Very preterm infants have significant delay in mental and physical development assessed at 24 months corrected age.
Sponsor: Swiss Neonatal Network

Current Primary Outcome: Mental developmental index (Bayley II) and motor, visual and hearing impairment [ Time Frame: at age of 24 months corrected for prematurity. ]

Original Primary Outcome:

  • incidence and severity of intracranial haemorrhage and white matter disease
  • assessed with ultrasound and MRI, mental developmental index (Bayley II)
  • and motor, visual and hearing impairment at 24 months corrected for prematurity.


Current Secondary Outcome:

  • MRI at term equivalent [ Time Frame: 40 postmenstrual weeks ]
    White matter injury score grey matter injury score brain maturation
  • cerebral palsy. [ Time Frame: First 24 months of life (corrected for prematurity) ]
  • Cognitive development and cerebral palsy [ Time Frame: 5 years ]

    Kaufmann ABC II, standardized neurological, visual and hearing examination, questionnaire about health status and behavior.

    Classification of impairments, disabilities and handicaps.



Original Secondary Outcome:

Information By: Swiss Neonatal Network

Dates:
Date Received: December 18, 2006
Date Started: January 2006
Date Completion:
Last Updated: February 23, 2015
Last Verified: February 2015