NCT00413946

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2006

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

6.9 years

First QC Date

December 18, 2006

Last Update Submit

October 27, 2018

Conditions

Intracranial HemorrhagePeriventricular LeukomalaciaCerebral PalsyDevelopmental Psychomotor Disorders

Keywords

Premature infantdevelopmental outcome

Outcome Measures

Primary Outcomes (1)

  • Mental developmental index (Bayley II) and motor, visual and hearing impairment

    at age of 24 months corrected for prematurity.

Secondary Outcomes (3)

  • MRI at term equivalent

    40 postmenstrual weeks

  • cerebral palsy.

    First 24 months of life (corrected for prematurity)

  • Cognitive development and cerebral palsy

    5 years

Study Arms (2)

Erythropoietin

EXPERIMENTAL

Three doses of rErythropoietin (3000 U/kg body weight) intravenously at 3, 12-18 and 36-42 hours after birth.

Drug: Recombinant human Erythropoietin

saline

PLACEBO COMPARATOR

Three doses of placebo (0.9% saline 1 ml/kg body weight) intravenously at 3, 12-18 and 36-42 hours after birth

Drug: saline

Interventions

Recombinant human ErythropoietinDRUG

3 doses 3000 units (1 ml) of recombinant human erythropoietin per kg body weight

Erythropoietin
salineDRUG

three doses of 1.0 ml saline per body weight

Also known as: NaCl 0.9%
saline

Eligibility Criteria

AgeUp to 3 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kantonsspital

Aarau, Switzerland

Location

Kantonsspital

Basel, Switzerland

Location

Kantonsspital

Chur, Switzerland

Location

Hopital universitaire

Geneva, Switzerland

Location

University Hospital

Zurich, CH-8091, Switzerland

Location

Related Publications (8)

  • Fauchere JC, Dame C, Vonthein R, Koller B, Arri S, Wolf M, Bucher HU. An approach to using recombinant erythropoietin for neuroprotection in very preterm infants. Pediatrics. 2008 Aug;122(2):375-82. doi: 10.1542/peds.2007-2591.

    PMID: 18676556RESULT

  • Picotti E, Reinelt T, Koller B, Bucher HU, Ruegger CM, Fauchere JC, Natalucci G; Swiss EPO Neuroprotection Trial Group. Effect of Early High-Dose Recombinant Human Erythropoietin on Behavior and Quality of Life in Children Aged 5 Years Born Very Preterm: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2245499. doi: 10.1001/jamanetworkopen.2022.45499.

    PMID: 36477478DERIVED

  • Natalucci G, Latal B, Koller B, Ruegger C, Sick B, Held L, Bucher HU, Fauchere JC; Swiss EPO Neuroprotection Trial Group. Effect of Early Prophylactic High-Dose Recombinant Human Erythropoietin in Very Preterm Infants on Neurodevelopmental Outcome at 2 Years: A Randomized Clinical Trial. JAMA. 2016 May 17;315(19):2079-85. doi: 10.1001/jama.2016.5504.

    PMID: 27187300DERIVED

  • Fauchere JC, Koller BM, Tschopp A, Dame C, Ruegger C, Bucher HU; Swiss Erythropoietin Neuroprotection Trial Group. Safety of Early High-Dose Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants. J Pediatr. 2015 Jul;167(1):52-7.e1-3. doi: 10.1016/j.jpeds.2015.02.052. Epub 2015 Apr 8.

    PMID: 25863661DERIVED

  • O'Gorman RL, Bucher HU, Held U, Koller BM, Huppi PS, Hagmann CF; Swiss EPO Neuroprotection Trial Group. Tract-based spatial statistics to assess the neuroprotective effect of early erythropoietin on white matter development in preterm infants. Brain. 2015 Feb;138(Pt 2):388-97. doi: 10.1093/brain/awu363. Epub 2014 Dec 22.

    PMID: 25534356DERIVED

  • Leuchter RH, Gui L, Poncet A, Hagmann C, Lodygensky GA, Martin E, Koller B, Darque A, Bucher HU, Huppi PS. Association between early administration of high-dose erythropoietin in preterm infants and brain MRI abnormality at term-equivalent age. JAMA. 2014 Aug 27;312(8):817-24. doi: 10.1001/jama.2014.9645.

    PMID: 25157725DERIVED

  • Ruegger CM, Kraus A, Koller B, Natalucci G, Latal B, Waldesbuhl E, Fauchere JC, Held L, Bucher HU. Randomized controlled trials in very preterm infants: does inclusion in the study result in any long-term benefit? Neonatology. 2014;106(2):114-9. doi: 10.1159/000362784. Epub 2014 Jun 20.

    PMID: 24969309DERIVED

  • Dame C, Langer J, Koller BM, Fauchere JC, Bucher HU. Urinary erythropoietin concentrations after early short-term infusion of high-dose recombinant epo for neuroprotection in preterm neonates. Neonatology. 2012;102(3):172-7. doi: 10.1159/000339283. Epub 2012 Jul 4.

    PMID: 22776958DERIVED

Related Links

MeSH Terms

Conditions

Intracranial HemorrhagesLeukomalacia, PeriventricularCerebral PalsyPsychomotor DisordersPremature Birth

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsEncephalomalaciaInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBrain Damage, ChronicNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Hans U Bucher, Prof

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
full professor of Neonatology

Study Record Dates

First Submitted

December 18, 2006

First Posted

December 20, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 30, 2018

Record last verified: 2018-10

Locations

CH(5)