Developmental DisabilitiesEPONCT02745990
Recombinant Human Erythropoietin Improve Neurodevelopmental Outcomes in Extremely Preterm Infants
A study testing Recombinant human erythropoietin and Normal saline in people with Developmental Disabilities, run by Huiqing Sun.
Trial summary
In the ELGAN (Extremely Low Gestational Age Newborn) study, abnormal brain structure and function were associated with intermittent or sustained systemic inflammation (ISSI). Since EPO has anti-inflammatory properties in the kidney and in muscle as well as growth/trophic properties. Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Developmental Disabilities
- What is being tested?
- Recombinant human erythropoietin and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2022
- Phase
- Interventional
- 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 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants admitted to NICU wuth gestational age less than 28 weeks
- Age less than 3 days;
- parental informed consent.
Who cannot join
- Major life-threatening anomalies (brain, cardiac, chromosomal anomalies)
- Hematologic crises such as DIC, or hemolysis due to blood group incompatibilities
- Polycythemia (hematocrit > 65);
- Hypertension
- Seizures
- Congenital infection
About this study
In the ELGAN (Extremely Low Gestational Age Newborn) study, abnormal brain structure and function were associated with intermittent or sustained systemic inflammation (ISSI). Since EPO has anti-inflammatory properties in the kidney and in muscle as well as growth/trophic properties. Based on its potential for neuroprotection, the prospective randomized and masked study was designed to determine whether rhEPO （500u/kg) was also effective in improving developmental outcomes for extremely low gestational age newborns.
Read the detailed description
Exogenous erythropoietin (EPO) is currently used to reduce or prevent the need for red blood cell transfusions in preterm infants. Just two decades ago, erythropoietin (EPO) receptors were first identified in the brain, and astrocytes were found to be capable of synthesizing EPO . Subsequently, it was found that cultured hippocampal and cerebral cortical neurons exposed to EPO were spared some of the glutamate-induced cell death seen in neurons not exposed to EPO. Thus began the concept that EPO protects the brain against adversity. Several follow-up studies of children who had participated in trials of recombinant EPO for the prevention or treatment of anemia, term newborn encephalopathy,or retinopathy of prematurity have also provided evidence of neuroprotective effects.
In the ELGAN (Extremely Low Gestational Age Newborn) study, abnormal brain structure and function were associated with intermittent or sustained systemic inflammation (ISSI) . Since EPO has anti-inflammatory properties in the kidney and in muscle as well as growth/trophic properties, we reasoned that elevated circulating levels might convey information about reduced risk of brain damage in ELGANs.
Although major neurodevelopmental disabilities such as cerebral palsy (CP), mental disabilities, and learning and attention deficits during school age figure prominently in the outcomes of ELBW infants, successful neuroprotective interventions have yet to be developed. Investagators designed a prospective, randomized, masked study to evaluate rhEPO during initial hospitalization and follow up, and hypothesized that rhEPO recipients would receive fewer transfusions during initial hospitalization in extremely preterm infants. Based on its potential for neuroprotection, our study was designed to determine whether rhEPO (500 u/kg) was also effective in improving developmental outcomes for extremely low gestational age newborns.
The neurodevelopmental outcomes of rhEPO in treating extremely preterm infants are not clear. Investigators propose an early-childhood neurodevelopmental follow-up study to compare long-term effects of the rhEPO as measured by, Bayley Scales of Infant Development III. We plan to follow extremely low gestational age children around 24 months' corrected age (CA) who are enrolled in this study.
- Conditions
- Developmental Disabilities
- Being tested
- Recombinant human erythropoietin, Normal saline
- Keywords
- erythropoietin, preterm, brain injury, cerebral palsy, PVL
- Medical subject headings
- Developmental Disabilities, Premature Birth, Brain Injuries, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human erythropoietinDrug
Also called Epoietin Beta
rhEPO is administered 500IU/kg, intravenously within 72h after birth, and every other day up to 32 weeks of corrected age.
Normal salineDrug
Normal salin is administered the same volume with rhEPO intravenously within 72h after birth, and every other day up to 32 weeks of corrected age..
| Study group | Role | What they receive |
|---|---|---|
| EPO group | Experimental | In EPO group, The recombinant human erythropoietin (rhEPO) will be given by 500 U/kg/dose intravenously within 72h after birth, and every other day up to 32 weeks of corrected age. Receives: Drug: Recombinant human erythropoietin |
| Normal saline | Placebo comparator | Normal saline is administered the same volume with EPO, intravenously within 72h after birth, and every other day up to 32 weeks of corrected age. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
To compare the death rate of EPO and control groups at 2 years old
Measured: 2 years
Incidence of neurological disability
To assess the incidence of neurological disability of EPO and control groups at 2 years old
Measured: 2 years
Secondary outcomes (7)
Incidence of MDI<70
To compare the incidence of MDI<70 via Bayley Scales of Infant Development between the two groups at 2 years old
Measured: 2 years
Incidence of cerebral palsy
To compare the incidence of cerebral palsy between the two groups at 2 years old
Measured: 2 years
Short-term complicatioins
Retinopathy of prematurity, periventricular leukomalacia,Intraventricular hemorrhage, necrotising enterocolitis and sepsis
Measured: 3 months
Incidence of blindness
To compare the incidence of blindness via visual acuity between the two groups at 2 years old
Measured: 2 years
Incidence of deafness
To compare the incidence of blindness via auditory brainstem response measurements between the two groups at 2 years old
Measured: 2 years
Early blood biomarkers for poor neurological outcomes
To investigate early blood biomarkers via multi-omics to predict poor neurological outcomes
Measured: 4 weeks
Brain imaging biomarkers for poor neurological outcomes
To investigate Brain imaging biomarkers via MRI to predict poor neurological outcomes
Measured: Up to 40 weeks of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Developmental DisabilitiesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huiqing Sun
- Sponsor type
- University, hospital or other
- Collaborators
- Zhengzhou University, Göteborg University
- Responsible party
- Sponsor-investigator, Huiqing Sun, Zhengzhou Children's Hospital, China
- Investigators
- Ligong Hou, BD, Study director, Zhengzhou Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745990
- Sponsor's protocol ID
- CZS-EPO
- Acronym
- EPO
- Status last verified
- Aug 2021
- First submitted
- 16 Mar 2016
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rees S, Harding R, Walker D. The biological basis of injury and neuroprotection in the fetal and neonatal brain. Int J Dev Neurosci. 2011 Oct;29(6):551-63. doi: 10.1016/j.ijdevneu.2011.04.004. Epub 2011 Apr 15.
PubMed 21527338Korzeniewski SJ, Allred E, Logan JW, Fichorova RN, Engelke S, Kuban KC, O'Shea TM, Paneth N, Holm M, Dammann O, Leviton A; ELGAN study investigators. Elevated endogenous erythropoietin concentrations are associated with increased risk of brain damage in extremely preterm neonates. PLoS One. 2015 Mar 20;10(3):e0115083. doi: 10.1371/journal.pone.0115083. eCollection 2015.
PubMed 25793991Moore EM, Bellomo R, Nichol AD. Erythropoietin as a novel brain and kidney protective agent. Anaesth Intensive Care. 2011 May;39(3):356-72. doi: 10.1177/0310057X1103900306.
PubMed 21675055Ohls RK, Kamath-Rayne BD, Christensen RD, Wiedmeier SE, Rosenberg A, Fuller J, Lacy CB, Roohi M, Lambert DK, Burnett JJ, Pruckler B, Peceny H, Cannon DC, Lowe JR. Cognitive outcomes of preterm infants randomized to darbepoetin, erythropoietin, or placebo. Pediatrics. 2014 Jun;133(6):1023-30. doi: 10.1542/peds.2013-4307. Epub 2014 May 12.
PubMed 24819566Zhu C, Kang W, Xu F, Cheng X, Zhang Z, Jia L, Ji L, Guo X, Xiong H, Simbruner G, Blomgren K, Wang X. Erythropoietin improved neurologic outcomes in newborns with hypoxic-ischemic encephalopathy. Pediatrics. 2009 Aug;124(2):e218-26. doi: 10.1542/peds.2008-3553. Epub 2009 Jul 27.
PubMed 19651565Brown MS, Eichorst D, Lala-Black B, Gonzalez R. Higher cumulative doses of erythropoietin and developmental outcomes in preterm infants. Pediatrics. 2009 Oct;124(4):e681-7. doi: 10.1542/peds.2008-2701. Epub 2009 Sep 28.
PubMed 19786428Leviton A, Kuban KC, Allred EN, Fichorova RN, O'Shea TM, Paneth N; ELGAN Study Investigators. Early postnatal blood concentrations of inflammation-related proteins and microcephaly two years later in infants born before the 28th post-menstrual week. Early Hum Dev. 2011 May;87(5):325-30. doi: 10.1016/j.earlhumdev.2011.01.043. Epub 2011 Feb 18.
PubMed 21334149O'Shea TM, Shah B, Allred EN, Fichorova RN, Kuban KCK, Dammann O, Leviton A; ELGAN Study Investigators. Inflammation-initiating illnesses, inflammation-related proteins, and cognitive impairment in extremely preterm infants. Brain Behav Immun. 2013 Mar;29:104-112. doi: 10.1016/j.bbi.2012.12.012. Epub 2013 Jan 4.
PubMed 23295265Lee SH, Li C, Lim SW, Ahn KO, Choi BS, Kim YS, Moon IS, Kim J, Bang BK, Yang CW. Attenuation of interstitial inflammation and fibrosis by recombinant human erythropoietin in chronic cyclosporine nephropathy. Am J Nephrol. 2005 Jan-Feb;25(1):64-76. doi: 10.1159/000084275. Epub 2005 Mar 2.
PubMed 15746540Contaldo C, Lindenblatt N, Elsherbiny A, Hogger DC, Borozadi MK, Vetter ST, Lang KS, Handschin AE, Giovanoli P. Erythropoietin requires endothelial nitric oxide synthase to counteract TNF-[alpha]-induced microcirculatory dysfunction in murine striated muscle. Shock. 2011 Mar;35(3):315-21. doi: 10.1097/SHK.0b013e3181fd0700.
PubMed 20926979Milne S, McDonald J, Comino EJ. The use of the Bayley Scales of Infant and Toddler Development III with clinical populations: a preliminary exploration. Phys Occup Ther Pediatr. 2012 Feb;32(1):24-33. doi: 10.3109/01942638.2011.592572. Epub 2011 Aug 4.
PubMed 21812743
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Erythropoietin Improve Neurodevelopmental Outcomes in Extremely Preterm Infants
- ClinicalTrials.gov ID
- NCT02745990
- Acronym / sponsor ID
- EPO / CZS-EPO
- Conditions
- Developmental Disabilities
- Keywords
- erythropoietin, preterm, brain injury, cerebral palsy, PVL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Huiqing SunUniversity, hospital or other
- Collaborators
- Zhengzhou University, Göteborg University
- Study start
- May 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Apr 2016 (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.
In the ELGAN (Extremely Low Gestational Age Newborn) study, abnormal brain structure and function were associated with intermittent or sustained systemic inflammation (ISSI). Since EPO has anti-inflammatory properties in the kidney and in muscle as well as growth/trophic properties. Based on its potential for neuroprotection, the prospective randomized and masked study was designed to determine whether rhEPO （500u/kg) was also effective in improving developmental outcomes for extremely low gestational age newborns.
Detailed description
Exogenous erythropoietin (EPO) is currently used to reduce or prevent the need for red blood cell transfusions in preterm infants. Just two decades ago, erythropoietin (EPO) receptors were first identified in the brain, and astrocytes were found to be capable of synthesizing EPO . Subsequently, it was found that cultured hippocampal and cerebral cortical neurons exposed to EPO were spared some of the glutamate-induced cell death seen in neurons not exposed to EPO. Thus began the concept that EPO protects the brain against adversity. Several follow-up studies of children who had participated in trials of recombinant EPO for the prevention or treatment of anemia, term newborn encephalopathy,or retinopathy of prematurity have also provided evidence of neuroprotective effects.
In the ELGAN (Extremely Low Gestational Age Newborn) study, abnormal brain structure and function were associated with intermittent or sustained systemic inflammation (ISSI) . Since EPO has anti-inflammatory properties in the kidney and in muscle as well as growth/trophic properties, we reasoned that elevated circulating levels might convey information about reduced risk of brain damage in ELGANs.
Although major neurodevelopmental disabilities such as cerebral palsy (CP), mental disabilities, and learning and attention deficits during school age figure prominently in the outcomes of ELBW infants, successful neuroprotective interventions have yet to be developed. Investagators designed a prospective, randomized, masked study to evaluate rhEPO during initial hospitalization and follow up, and hypothesized that rhEPO recipients would receive fewer transfusions during initial hospitalization in extremely preterm infants. Based on its potential for neuroprotection, our study was designed to determine whether rhEPO (500 u/kg) was also effective in improving developmental outcomes for extremely low gestational age newborns.
The neurodevelopmental outcomes of rhEPO in treating extremely preterm infants are not clear. Investigators propose an early-childhood neurodevelopmental follow-up study to compare long-term effects of the rhEPO as measured by, Bayley Scales of Infant Development III. We plan to follow extremely low gestational age children around 24 months' corrected age (CA) who are enrolled in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPO group | Experimental | Drug: Recombinant human erythropoietinIn EPO group, The recombinant human erythropoietin (rhEPO) will be given by 500 U/kg/dose intravenously within 72h after birth, and every other day up to 32 weeks of corrected age. |
| Normal saline | Placebo comparator | Drug: Normal salineNormal saline is administered the same volume with EPO, intravenously within 72h after birth, and every other day up to 32 weeks of corrected age. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants admitted to NICU wuth gestational age less than 28 weeks
- Age less than 3 days;
- parental informed consent.
Key exclusion criteria (6 listed)
- Major life-threatening anomalies (brain, cardiac, chromosomal anomalies)
- Hematologic crises such as DIC, or hemolysis due to blood group incompatibilities
- Polycythemia (hematocrit > 65);
- Hypertension
- Seizures
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 erythropoietinAlso: Epoietin BetarhEPO is administered 500IU/kg, intravenously within 72h after birth, and every other day up to 32 weeks of corrected age. | Drug | EPO group |
| Normal salineNormal salin is administered the same volume with rhEPO intravenously within 72h after birth, and every other day up to 32 weeks of corrected age.. | Drug | Normal saline |
Primary outcome
Mortality
Time frame: 2 years
To compare the death rate of EPO and control groups at 2 years old
Incidence of neurological disability
Time frame: 2 years
To assess the incidence of neurological disability of EPO and control groups at 2 years old
7 secondary outcomes
Incidence of MDI<70
Time frame: 2 years
Incidence of cerebral palsy
Time frame: 2 years
Short-term complicatioins
Time frame: 3 months
Incidence of blindness
Time frame: 2 years
Incidence of deafness
Time frame: 2 years
Early blood biomarkers for poor neurological outcomes
Time frame: 4 weeks
Brain imaging biomarkers for poor neurological outcomes
Time frame: Up to 40 weeks of corrected age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Results publication: PubMed 21527338Rees S, Harding R, Walker D. The biological basis of injury and neuroprotection in the fetal and neonatal brain. Int J Dev Neurosci. 2011 Oct;29(6):551-63. doi: 10.1016/j.ijdevneu.2011.04.004. Epub 2011 Apr 15.
- Results publication: PubMed 25793991Korzeniewski SJ, Allred E, Logan JW, Fichorova RN, Engelke S, Kuban KC, O'Shea TM, Paneth N, Holm M, Dammann O, Leviton A; ELGAN study investigators. Elevated endogenous erythropoietin concentrations are associated with increased risk of brain damage in extremely preterm neonates. PLoS One. 2015 Mar 20;10(3):e0115083. doi: 10.1371/journal.pone.0115083. eCollection 2015.
- Results publication: PubMed 21675055Moore EM, Bellomo R, Nichol AD. Erythropoietin as a novel brain and kidney protective agent. Anaesth Intensive Care. 2011 May;39(3):356-72. doi: 10.1177/0310057X1103900306.
- Results publication: PubMed 24819566Ohls RK, Kamath-Rayne BD, Christensen RD, Wiedmeier SE, Rosenberg A, Fuller J, Lacy CB, Roohi M, Lambert DK, Burnett JJ, Pruckler B, Peceny H, Cannon DC, Lowe JR. Cognitive outcomes of preterm infants randomized to darbepoetin, erythropoietin, or placebo. Pediatrics. 2014 Jun;133(6):1023-30. doi: 10.1542/peds.2013-4307. Epub 2014 May 12.
- Results publication: PubMed 19651565Zhu C, Kang W, Xu F, Cheng X, Zhang Z, Jia L, Ji L, Guo X, Xiong H, Simbruner G, Blomgren K, Wang X. Erythropoietin improved neurologic outcomes in newborns with hypoxic-ischemic encephalopathy. Pediatrics. 2009 Aug;124(2):e218-26. doi: 10.1542/peds.2008-3553. Epub 2009 Jul 27.
- Results publication: PubMed 19786428Brown MS, Eichorst D, Lala-Black B, Gonzalez R. Higher cumulative doses of erythropoietin and developmental outcomes in preterm infants. Pediatrics. 2009 Oct;124(4):e681-7. doi: 10.1542/peds.2008-2701. Epub 2009 Sep 28.
- Results publication: PubMed 21334149Leviton A, Kuban KC, Allred EN, Fichorova RN, O'Shea TM, Paneth N; ELGAN Study Investigators. Early postnatal blood concentrations of inflammation-related proteins and microcephaly two years later in infants born before the 28th post-menstrual week. Early Hum Dev. 2011 May;87(5):325-30. doi: 10.1016/j.earlhumdev.2011.01.043. Epub 2011 Feb 18.
- Results publication: PubMed 23295265O'Shea TM, Shah B, Allred EN, Fichorova RN, Kuban KCK, Dammann O, Leviton A; ELGAN Study Investigators. Inflammation-initiating illnesses, inflammation-related proteins, and cognitive impairment in extremely preterm infants. Brain Behav Immun. 2013 Mar;29:104-112. doi: 10.1016/j.bbi.2012.12.012. Epub 2013 Jan 4.
- Results publication: PubMed 15746540Lee SH, Li C, Lim SW, Ahn KO, Choi BS, Kim YS, Moon IS, Kim J, Bang BK, Yang CW. Attenuation of interstitial inflammation and fibrosis by recombinant human erythropoietin in chronic cyclosporine nephropathy. Am J Nephrol. 2005 Jan-Feb;25(1):64-76. doi: 10.1159/000084275. Epub 2005 Mar 2.
- Results publication: PubMed 20926979Contaldo C, Lindenblatt N, Elsherbiny A, Hogger DC, Borozadi MK, Vetter ST, Lang KS, Handschin AE, Giovanoli P. Erythropoietin requires endothelial nitric oxide synthase to counteract TNF-[alpha]-induced microcirculatory dysfunction in murine striated muscle. Shock. 2011 Mar;35(3):315-21. doi: 10.1097/SHK.0b013e3181fd0700.
- Results publication: PubMed 21812743Milne S, McDonald J, Comino EJ. The use of the Bayley Scales of Infant and Toddler Development III with clinical populations: a preliminary exploration. Phys Occup Ther Pediatr. 2012 Feb;32(1):24-33. doi: 10.3109/01942638.2011.592572. Epub 2011 Aug 4.
- Individual participant dataSharing planned: No
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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.
Ligong Hou, BD study director
Zhengzhou Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant human erythropoietin and Normal saline in people with Developmental Disabilities, run by Huiqing Sun.
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 6 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: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Mortality (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT02745990, which also lists 11 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 31 Aug 2021.