Premature BirthPhase 4EPONCT02036073
Effect of Erythropoietin on Preterm Brain Injury
A Phase 4 study testing recombinant human erythropoietin in people with Premature Birth, run by Zhengzhou Children's Hospital, China at 1 site in China.
Trial summary
EPO has been safely used for prevent preterm anemia and recent studies have shown the neuroprotective effect. Our hypothesis is that EPO could prevent preterm brain injury. The aims of this study include: to investigate the safety and efficacy of EPO by using 500u/kg higher than the dose of anemia treatment (250u/kg)… Read more about this study
- Who is it for?
- Ages 1 day to 72 days
- Conditions the study is for
- Premature Birth
- What is being tested?
- recombinant human erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2013
- Phase
- Phase 4
- 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 72 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants admitted to the NICU with gestational age <32 weeks
- birth weight <1500g and less than 72hours of age
Who cannot join
- 1. Infants with genetic metabolic diseases
- 2. Congenital abnormalities
- 3. Pneumothorax
- 4. Grade III-IV intracranial hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
EPO has been safely used for prevent preterm anemia and recent studies have shown the neuroprotective effect. Our hypothesis is that EPO could prevent preterm brain injury. The aims of this study include: to investigate the safety and efficacy of EPO by using 500u/kg higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on neurodevelopment in preterm infants; to detect biological indicators and explore the neuroprotective mechanism of EPO.
Read the detailed description
Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in preterm infants, which is related with the development of cerebral palsy. The current therapy is only supportive to maintain the live sign stable. There is no effective therapeutic strategy for preterm brain injury. Erythropoietin (EPO) has been shown to be protective against hypoxic-ischemic and inflammatory injuries in animal models of brain injury, and clinical trials of neonatal hypoxic ischemic brain injury. Furthermore, recombinant human Epo (rhEpo) has been widely used in preterm infants to prevent or treat the anemia of prematurity during the past decade. It has been considered to be safe and well tolerated in preterm infants. However, there is no conclusion yet if the EPO has the effect to prevent preterm brain injury. The purpose of the study was whether the rhEpo (500 U/kg) given to very preterm infants (gestation age < 32 weeks) within 24h after birth and subsequently each other day for2 week possesses neuroprotective properties. Very preterm infants with gestational age of < 32 weeks and admit to our NICU are eligible for enrollment. After informed consent is obtained, infants will be randomly assigned to either EPO group or vehicle group. The primary short-term outcome measures are brain injury (intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL)) and ROP. The long term outcomes are whether rhEpo in very preterm infants finally improves neurodevelopmental outcome at 18 months corrected age.
- Conditions
- Premature Birth
- Being tested
- recombinant human erythropoietin
- Keywords
- erythropoietin, preterm, brain injury, cerebral palsy, PVL
- Medical subject headings
- 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 EPO
rhEPO 500U/kg was injected within 24h after birth, subsequent injection was given each other day fro 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| EPO | Experimental | In EPO group, the EPO was given by 500IU/kg every other day intravenously for 2 weeks. Recombinant human erythropoietin was configured by the hospital pharmacy intravenous Center Configuration, melted configured with saline to 1ml/kg solution. For severe patients, they were started to treat with EPO when their vital signs, blood pressure were stable. Receives: Drug: recombinant human erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MDI<70
Measured: At corrected age of 18 months
Secondary outcomes (1)
Incidence of ROP
Measured: At the corrected age 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2009
- Primary completionJun 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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 4
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengzhou Children's Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Zhengzhou University
- Responsible party
- Principal investigator, Huiqing Sun, Zhengzhou Children's Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036073
- Sponsor's protocol ID
- CZZ-EPO
- Acronym
- EPO
- Status last verified
- Jan 2014
- First submitted
- 10 Dec 2013
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sun H, Song J, Kang W, Wang Y, Sun X, Zhou C, Xiong H, Xu F, Li M, Zhang X, Yu Z, Peng X, Li B, Xu Y, Xing S, Wang X, Zhu C. Effect of early prophylactic low-dose recombinant human erythropoietin on retinopathy of prematurity in very preterm infants. J Transl Med. 2020 Oct 19;18(1):397. doi: 10.1186/s12967-020-02562-y.
PubMed 33076939
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Erythropoietin on Preterm Brain Injury
- ClinicalTrials.gov ID
- NCT02036073
- Acronym / sponsor ID
- EPO / CZZ-EPO
- Conditions
- Premature Birth
- Keywords
- erythropoietin, preterm, brain injury, cerebral palsy, PVL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Zhengzhou Children's Hospital, ChinaUniversity, hospital or other
- Collaborators
- Zhengzhou University
- Study start
- Jan 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Jan 2014 (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.
EPO has been safely used for prevent preterm anemia and recent studies have shown the neuroprotective effect. Our hypothesis is that EPO could prevent preterm brain injury. The aims of this study include: to investigate the safety and efficacy of EPO by using 500u/kg higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on neurodevelopment in preterm infants; to detect biological indicators and explore the neuroprotective mechanism of EPO.
Detailed description
Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in preterm infants, which is related with the development of cerebral palsy. The current therapy is only supportive to maintain the live sign stable. There is no effective therapeutic strategy for preterm brain injury. Erythropoietin (EPO) has been shown to be protective against hypoxic-ischemic and inflammatory injuries in animal models of brain injury, and clinical trials of neonatal hypoxic ischemic brain injury. Furthermore, recombinant human Epo (rhEpo) has been widely used in preterm infants to prevent or treat the anemia of prematurity during the past decade. It has been considered to be safe and well tolerated in preterm infants. However, there is no conclusion yet if the EPO has the effect to prevent preterm brain injury. The purpose of the study was whether the rhEpo (500 U/kg) given to very preterm infants (gestation age < 32 weeks) within 24h after birth and subsequently each other day for2 week possesses neuroprotective properties. Very preterm infants with gestational age of < 32 weeks and admit to our NICU are eligible for enrollment. After informed consent is obtained, infants will be randomly assigned to either EPO group or vehicle group. The primary short-term outcome measures are brain injury (intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL)) and ROP. The long term outcomes are whether rhEpo in very preterm infants finally improves neurodevelopmental outcome at 18 months corrected age.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPO | Experimental | Drug: recombinant human erythropoietinIn EPO group, the EPO was given by 500IU/kg every other day intravenously for 2 weeks. Recombinant human erythropoietin was configured by the hospital pharmacy intravenous Center Configuration, melted configured with saline to 1ml/kg solution. For severe patients, they were started to treat with EPO when their vital signs, blood pressure were stable. |
Who may qualify
- Ages
- 1 day to 72 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants admitted to the NICU with gestational age <32 weeks
- birth weight <1500g and less than 72hours of age
Key exclusion criteria (4 listed)
- 1. Infants with genetic metabolic diseases
- 2. Congenital abnormalities
- 3. Pneumothorax
- 4. Grade III-IV intracranial hemorrhage
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: EPOrhEPO 500U/kg was injected within 24h after birth, subsequent injection was given each other day fro 2 weeks. | Drug | EPO |
Primary outcome
Incidence of MDI<70
Time frame: At corrected age of 18 months
1 secondary outcome
Incidence of ROP
Time frame: At the corrected age 42 weeks
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 14 Jan 2014.
- Derived from this study: PubMed 33076939Sun H, Song J, Kang W, Wang Y, Sun X, Zhou C, Xiong H, Xu F, Li M, Zhang X, Yu Z, Peng X, Li B, Xu Y, Xing S, Wang X, Zhu C. Effect of early prophylactic low-dose recombinant human erythropoietin on retinopathy of prematurity in very preterm infants. J Transl Med. 2020 Oct 19;18(1):397. doi: 10.1186/s12967-020-02562-y.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing recombinant human erythropoietin in people with Premature Birth, run by Zhengzhou Children's Hospital, China at 1 site in China.
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 2 inclusion and 4 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 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of MDI<70 (time frame: At corrected age of 18 months). 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 NCT02036073, which also lists 1 linked publication.
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 14 Jan 2014.