Does Erythropoietin Improve Outcome in Very Preterm Infants?

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Bucher Hans Ulrich, Swiss Neonatal Network
ClinicalTrials.gov Identifier:
NCT00413946
First received: December 18, 2006
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Intracranial Hemorrhage
Periventricular Leukomalacia
Cerebral Palsy
Neurodevelopmental Delay
Drug: Recombinant human Erythropoietin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Neuroprotective Effect of High Dose Erythropoietin in Very Preterm Infants

Resource links provided by NLM:


Further study details as provided by Swiss Neonatal Network:

Primary Outcome Measures:
  • Mental developmental index (Bayley II) and motor, visual and hearing impairment [ Time Frame: at age of 24 months corrected for prematurity. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRI at term equivalent [ Time Frame: 40 postmenstrual weeks ] [ Designated as safety issue: No ]
    White matter injury score grey matter injury score brain maturation

  • cerebral palsy. [ Time Frame: First 24 months of life (corrected for prematurity) ] [ Designated as safety issue: No ]
  • Cognitive development and cerebral palsy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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

    Classification of impairments, disabilities and handicaps.



Enrollment: 420
Study Start Date: January 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rEpo
Three doses of rEryhtropoietin (3000 U/kg body weight) intravenously at 3, 12-18 and 36-42 hours after birth.
Drug: Recombinant human Erythropoietin
3 doses 3000 units (1 ml) of rEpo or 1 ml of saline per kg body weight
Placebo Comparator: saline
Three doses of placebo (0.9% saline 1 ml/kg body weight) intravenously at 3, 12-18 and 36-42 hours after birth
Drug: Recombinant human Erythropoietin
3 doses 3000 units (1 ml) of rEpo or 1 ml of saline per kg body weight

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 3 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants born between 26 0/7 and 31 6/7 gestational weeks
  • Postnatal age less than 3 hours
  • Informed parental consent (preferably obtained before birth)

Exclusion Criteria:

  • Genetically defined syndrome
  • Severe congenital malformation adversely affecting life expectancy
  • Severe congenital malformation adversely affecting neurodevelopment
  • A priory palliative care
  • Intracranial haemorrhage grade 3 or more detected before dose 3 of Erythropoietin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413946

Locations
Switzerland
Kantonsspital
Aarau, Switzerland
Kantonsspital
Basel, Switzerland
Kantonsspital
Chur, Switzerland
Hopital universitaire
Geneva, Switzerland
University Hospital
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Neonatal Network
Swiss National Science Foundation
Investigators
Principal Investigator: Hans U Bucher, Prof University of Zurich
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bucher Hans Ulrich, full professor of Neonatology, Swiss Neonatal Network
ClinicalTrials.gov Identifier: NCT00413946     History of Changes
Other Study ID Numbers: 3200B0-108176, RoFAR ID 2127989593, 3200B0-108176
Study First Received: December 18, 2006
Last Updated: May 19, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Neonatal Network:
Premature infant
developmental outcome

Additional relevant MeSH terms:
Hemorrhage
Cerebral Palsy
Intracranial Hemorrhages
Leukomalacia, Periventricular
Pathologic Processes
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Encephalomalacia
Infant, Premature, Diseases
Infant, Newborn, Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014