Intracranial HemorrhagePhase 2NCT00413946
Does Erythropoietin Improve Outcome in Very Preterm Infants?
A Phase 2 study testing Recombinant human Erythropoietin and saline in people with Intracranial Hemorrhage and Periventricular Leukomalacia, run by Swiss Neonatal Network at 5 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 hours
- Conditions the study is for
- Intracranial Hemorrhage, Periventricular Leukomalacia, Cerebral Palsy
- What is being tested?
- Recombinant human Erythropoietin and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 5 sitesSwitzerland
- Study dates
- Jan 2006to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Switzerland5 sites
Kantonsspital
Aarau
Kantonsspital
Basel
Kantonsspital
Chur
Hopital universitaire
Geneva
University Hospital
Zurich, CH-8091
About this study
Official title: Neuroprotective Effect of High Dose Erythropoietin in Very Preterm Infants
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.
Read the detailed description
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. The most critical period are the first days after preterm birth where the oxygenation of the brain may be impaired by respiratory, circulatory and nutritional insufficiency. Although there are probably several mechanisms involved in permanent brain damage, it is most likely that EPO with its multiple action may reduce this damage.
EPO has been studied in several trials in preterm infants to prevent anaemia and is now widely used for this indication.
STUDY DESIGN Randomized, double-masked, placebo-controlled multicenter clinical trial. Research plan 420 infants will be randomized during the first three hours of life to receive EPO (3000 U/kg body weight) or placebo intravenously at 3, 12-18 and 36-42 hours after birth. Standardized evaluation including cerebral sonography at day 1 and 7 and at 36 0/7 gestational weeks (or at discharge home if discharged before) will determine the presence or absence of complications. Cerebral volume and white matter volume will be assessed at 40 postmenstrual weeks with MRI (only if available).
Experienced examiners will assess developmental function at 24 months corrected age using the reliable and validly revised Bayley Scales II of Infant Development and determine the presence or absence of impairment of motor function (cerebral palsy) and neurosensory function (blindness or deafness).
CLINICAL SIGNIFICANCE At least 1 of every 100 live born infants is born very preterm. 90% of these infants survive but >50% have a delay in mental and physical development assessed at 24 months corrected age. More subtle problems affecting cognition, vision and hearing are common at the age of five years and have an impact on school performance and quality of life of the infants and their families. The aim of this trial is to examine whether a short, easily applicable and well tolerated pharmacological intervention can improve neurodevelopmental outcome.
- Conditions
- Intracranial Hemorrhage, Periventricular Leukomalacia, Cerebral Palsy, Developmental Psychomotor Disorders
- Being tested
- Recombinant human Erythropoietin, saline
- Keywords
- Premature infant, developmental outcome
- Medical subject headings
- Intracranial Hemorrhages, Leukomalacia, Periventricular, Cerebral Palsy, Psychomotor Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human ErythropoietinDrug
3 doses 3000 units (1 ml) of recombinant human erythropoietin per kg body weight
salineDrug
Also called NaCl 0.9%
three doses of 1.0 ml saline per body weight
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin | Experimental | Three doses of rErythropoietin (3000 U/kg body weight) intravenously at 3, 12-18 and 36-42 hours after birth. Receives: 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 Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental developmental index (Bayley II) and motor, visual and hearing impairment
Measured: at age of 24 months corrected for prematurity.
Secondary outcomes (3)
MRI at term equivalent
White matter injury score grey matter injury score brain maturation
Measured: 40 postmenstrual weeks
cerebral palsy.
Measured: First 24 months of life (corrected for prematurity)
Cognitive development and cerebral palsy
Kaufmann ABC II, standardized neurological, visual and hearing examination, questionnaire about health status and behavior.
Classification of impairments, disabilities and handicaps.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intracranial HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Neonatal Network
- Sponsor type
- Research network
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Bucher Hans Ulrich, Swiss Neonatal Network
- Investigators
- Hans U Bucher, Prof, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413946
- Sponsor's protocol ID
- 3200B0-108176
- Other IDs
- RoFAR ID 2127989593, 3200B0-108176
- Status last verified
- Oct 2018
- First submitted
- 18 Dec 2006
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18676556Picotti 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.
PubMed 36477478Natalucci 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.
PubMed 27187300Fauchere 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.
PubMed 25863661O'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.
PubMed 25534356Leuchter 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.
PubMed 25157725Ruegger 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.
PubMed 24969309Dame 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.
PubMed 22776958
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotective Effect of High Dose Erythropoietin in Very Preterm Infants
- ClinicalTrials.gov ID
- NCT00413946
- Acronym / sponsor ID
- 3200B0-108176
- Conditions
- Intracranial Hemorrhage, Periventricular Leukomalacia, Cerebral Palsy, Developmental Psychomotor Disorders
- Keywords
- Premature infant, developmental outcome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Swiss Neonatal NetworkResearch network
- Collaborators
- Swiss National Science Foundation
- Study start
- Jan 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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. The most critical period are the first days after preterm birth where the oxygenation of the brain may be impaired by respiratory, circulatory and nutritional insufficiency. Although there are probably several mechanisms involved in permanent brain damage, it is most likely that EPO with its multiple action may reduce this damage.
EPO has been studied in several trials in preterm infants to prevent anaemia and is now widely used for this indication.
STUDY DESIGN Randomized, double-masked, placebo-controlled multicenter clinical trial. Research plan 420 infants will be randomized during the first three hours of life to receive EPO (3000 U/kg body weight) or placebo intravenously at 3, 12-18 and 36-42 hours after birth. Standardized evaluation including cerebral sonography at day 1 and 7 and at 36 0/7 gestational weeks (or at discharge home if discharged before) will determine the presence or absence of complications. Cerebral volume and white matter volume will be assessed at 40 postmenstrual weeks with MRI (only if available).
Experienced examiners will assess developmental function at 24 months corrected age using the reliable and validly revised Bayley Scales II of Infant Development and determine the presence or absence of impairment of motor function (cerebral palsy) and neurosensory function (blindness or deafness).
CLINICAL SIGNIFICANCE At least 1 of every 100 live born infants is born very preterm. 90% of these infants survive but >50% have a delay in mental and physical development assessed at 24 months corrected age. More subtle problems affecting cognition, vision and hearing are common at the age of five years and have an impact on school performance and quality of life of the infants and their families. The aim of this trial is to examine whether a short, easily applicable and well tolerated pharmacological intervention can improve neurodevelopmental outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin | Experimental | Drug: Recombinant human ErythropoietinThree doses of rErythropoietin (3000 U/kg body weight) intravenously at 3, 12-18 and 36-42 hours after birth. |
| saline | Placebo comparator | Drug: salineThree doses of placebo (0.9% saline 1 ml/kg body weight) intravenously at 3, 12-18 and 36-42 hours after birth |
Who may qualify
- Ages
- Up to 3 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human Erythropoietin3 doses 3000 units (1 ml) of recombinant human erythropoietin per kg body weight | Drug | Erythropoietin |
| salineAlso: NaCl 0.9%three doses of 1.0 ml saline per body weight | Drug | saline |
Primary outcome
Mental developmental index (Bayley II) and motor, visual and hearing impairment
Time frame: at age of 24 months corrected for prematurity.
3 secondary outcomes
MRI at term equivalent
Time frame: 40 postmenstrual weeks
cerebral palsy.
Time frame: First 24 months of life (corrected for prematurity)
Cognitive development and cerebral palsy
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Results publication: PubMed 18676556Fauchere 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.
- Derived from this study: PubMed 36477478Picotti 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.
- Derived from this study: PubMed 27187300Natalucci 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.
- Derived from this study: PubMed 25863661Fauchere 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.
- Derived from this study: PubMed 25534356O'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.
- Derived from this study: PubMed 25157725Leuchter 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.
- Derived from this study: PubMed 24969309Ruegger 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.
- Derived from this study: PubMed 22776958Dame 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.
- Swiss Neonatal NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans U Bucher, Prof principal investigator
University of Zurich
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human Erythropoietin and saline in people with Intracranial Hemorrhage and Periventricular Leukomalacia, run by Swiss Neonatal Network at 5 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental developmental index (Bayley II) and motor, visual and hearing impairment (time frame: at age of 24 months corrected for prematurity.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00413946, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.