Premature InfantsPhase 2NCT03914690
Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage
A Phase 2 study testing Erythropoietin and Normal saline in people with Premature Infants, run by Zhengzhou University at 1 site in China.
Trial summary
Erythropoietin (EPO) has been shown to be neurotrophic and neuroprotective in several animal models and some clinical studies. Our hypothesis is that EPO could improve long-term neurological outcomes in very preterm infants with intraventricular hemorrhage (IVH). Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Premature Infants
- What is being tested?
- 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
- 316 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jul 2019
- 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 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants admitted to NICU ≤ 32 weeks gestation at birth
- Birth weight less than 1500 g
- Less than 72 hours of life at time of enrolment
- Diagnosed as IVH by head ultrasound
- Written informed consent of parent or guardian
Who cannot join
- Genetic metabolic diseases
- Congenital abnormalities
- Polycythaemia (Hct > 65%) within first 24 hours of life
- Thrombocytopenia (platelets < 50K cells/microL) within first 24 hours of life
- Unstable vital signs (such as respiration and circulation failure)
Trial locations and contacts
1 site in 1 country.
China1 site
Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Erythropoietin (EPO) has been shown to be neurotrophic and neuroprotective in several animal models and some clinical studies. Our hypothesis is that EPO could improve long-term neurological outcomes in very preterm infants with intraventricular hemorrhage (IVH). The aim of this study is to evaluate the long-term neuroprotective effect of repeated low-dose EPO (500 U/kg) in very preterm infants with IVH.
Read the detailed description
IVH is one of the most common complications in preterm infants. Nearly 60% of preterm infants with grade III-IV IVH develop severe neurodevelopmental outcomes. There are currently no effective treatments to prevent preterm infants with IVH from developing ventricular dilation or serious neurological disabilities. Recent studies have shown that EPO could improve neurodevelopmental outcomes in preterm infants with grade III-IV IVH. However, the dose and course of EPO in preterm infants is still uncertain. The purpose of the study was whether repeated low-dose EPO (500 U/kg, every other day, for 2 weeks) given to very preterm right after the diagnosis of IVH could improve long-term neurological outcomes. Very preterm infants with gestational age of ≤ 32 weeks who are diagnosed with IVH within 72 hours after birth in NICU are eligible for enrolment. After informed consent is obtained, infants will be randomly assigned to EPO group or vehicle group. The primary outcome is whether EPO improves mortality and neurological disabilities in very preterm infants with IVH at 18 months of corrected age, and the secondary outcome was whether EPO decrease the incidence of cerebral palsy, MDI<70, blindness, and deafness.
- Conditions
- Premature Infants
- Being tested
- Erythropoietin, Normal saline
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
Also called Epoietin Beta
EPO is administered 500IU/kg, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks.
Normal salineDrug
Normal saline is administered the same volume with EPO, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin | Experimental | EPO is administered 500IU/kg, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks. Recombinant human erythropoietin was configured by the hospital pharmacy intravenous Centre Configuration, melted configured with saline to 1ml/kg solution. Receives: Drug: Erythropoietin |
| Normal saline | Placebo comparator | Normal saline is administered the same volume with EPO, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks. 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 in EPO treatment and control groups at 18 months of corrected age.
Measured: At corrected age of 18 months
Incidence of neurological disability
To evaluate neurodevelopmental function via Bayley Infant Development scale (2nd Edition), visual acuity and auditory brainstem response measurements at 18 months of corrected age.
Measured: At corrected age of 18 months
Secondary outcomes (5)
Incidence of cerebral palsy
To compare the incidence of cerebral palsy in EPO treatment and control groups at 18 months of corrected age.
Measured: At corrected age of 18 months
Incidence of MDI<70
To compare the incidence of MDI<70 via Bayley Infant Development scale (2nd Edition) in EPO treatment and control groups at 18 months of corrected age.
Measured: At corrected age of 18 months
Incidence of blindness
To compare the incidence of blindness via visual acuity and sight radius examinations in EPO treatment and control groups at 18 months of corrected age.
Measured: At corrected age of 18 months
Incidence of deafness
To compare the incidence of deafness via auditory brainstem response measurements in EPO treatment and control groups at 18 months of corrected age.
Measured: At corrected age of 18 months
The effect of EPO treatment on blood mRNA expression
To investigate different mRNA expression between EPO and control group, peripheral venous blood of preterm infants after EPO treatment will be collected in both EPO group and control group, and the transcriptome of the premature infant blood will be assayed by RNA sequencing.
Measured: At 3 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study startJul 2014
- Primary completionJul 2019
- Study completionJul 2019
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 InfantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhengzhou Children's Hospital, China, Göteborg University
- Responsible party
- Principal investigator, Changlian Zhu, Third Affiliated Hospital of Zhengzhou University
- Investigators
- Changlian Zhu, PhD, Study chair, Third Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914690
- Sponsor's protocol ID
- EPO2014
- Status last verified
- Feb 2021
- First submitted
- 11 Apr 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song J, Wang Y, Xu F, Sun H, Zhang X, Xia L, Zhang S, Li K, Peng X, Li B, Zhang Y, Kang W, Wang X, Zhu C. Erythropoietin Improves Poor Outcomes in Preterm Infants with Intraventricular Hemorrhage. CNS Drugs. 2021 Jun;35(6):681-690. doi: 10.1007/s40263-021-00817-w. Epub 2021 May 6.
PubMed 33959935
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage
- ClinicalTrials.gov ID
- NCT03914690
- Acronym / sponsor ID
- EPO2014
- Conditions
- Premature Infants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Zhengzhou Children's Hospital, China, Göteborg University
- Study start
- Jul 2014 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 16 Apr 2019 (actual)
- 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.
Erythropoietin (EPO) has been shown to be neurotrophic and neuroprotective in several animal models and some clinical studies. Our hypothesis is that EPO could improve long-term neurological outcomes in very preterm infants with intraventricular hemorrhage (IVH). The aim of this study is to evaluate the long-term neuroprotective effect of repeated low-dose EPO (500 U/kg) in very preterm infants with IVH.
Detailed description
IVH is one of the most common complications in preterm infants. Nearly 60% of preterm infants with grade III-IV IVH develop severe neurodevelopmental outcomes. There are currently no effective treatments to prevent preterm infants with IVH from developing ventricular dilation or serious neurological disabilities. Recent studies have shown that EPO could improve neurodevelopmental outcomes in preterm infants with grade III-IV IVH. However, the dose and course of EPO in preterm infants is still uncertain. The purpose of the study was whether repeated low-dose EPO (500 U/kg, every other day, for 2 weeks) given to very preterm right after the diagnosis of IVH could improve long-term neurological outcomes. Very preterm infants with gestational age of ≤ 32 weeks who are diagnosed with IVH within 72 hours after birth in NICU are eligible for enrolment. After informed consent is obtained, infants will be randomly assigned to EPO group or vehicle group. The primary outcome is whether EPO improves mortality and neurological disabilities in very preterm infants with IVH at 18 months of corrected age, and the secondary outcome was whether EPO decrease the incidence of cerebral palsy, MDI<70, blindness, and deafness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin | Experimental | Drug: ErythropoietinEPO is administered 500IU/kg, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks. Recombinant human erythropoietin was configured by the hospital pharmacy intravenous Centre Configuration, melted configured with saline to 1ml/kg solution. |
| Normal saline | Placebo comparator | Drug: Normal salineNormal saline is administered the same volume with EPO, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks. |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm infants admitted to NICU ≤ 32 weeks gestation at birth
- Birth weight less than 1500 g
- Less than 72 hours of life at time of enrolment
- Diagnosed as IVH by head ultrasound
- Written informed consent of parent or guardian
Key exclusion criteria (5 listed)
- Genetic metabolic diseases
- Congenital abnormalities
- Polycythaemia (Hct > 65%) within first 24 hours of life
- Thrombocytopenia (platelets < 50K cells/microL) within first 24 hours of life
- Unstable vital signs (such as respiration and circulation failure)
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 |
|---|---|---|
| ErythropoietinAlso: Epoietin BetaEPO is administered 500IU/kg, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks. | Drug | Erythropoietin |
| Normal salineNormal saline is administered the same volume with EPO, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks. | Drug | Normal saline |
Primary outcome
Mortality
Time frame: At corrected age of 18 months
To compare the death rate in EPO treatment and control groups at 18 months of corrected age.
Incidence of neurological disability
Time frame: At corrected age of 18 months
To evaluate neurodevelopmental function via Bayley Infant Development scale (2nd Edition), visual acuity and auditory brainstem response measurements at 18 months of corrected age.
5 secondary outcomes
Incidence of cerebral palsy
Time frame: At corrected age of 18 months
Incidence of MDI<70
Time frame: At corrected age of 18 months
Incidence of blindness
Time frame: At corrected age of 18 months
Incidence of deafness
Time frame: At corrected age of 18 months
The effect of EPO treatment on blood mRNA expression
Time frame: At 3 weeks after birth
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 26 Feb 2021.
- Derived from this study: PubMed 33959935Song J, Wang Y, Xu F, Sun H, Zhang X, Xia L, Zhang S, Li K, Peng X, Li B, Zhang Y, Kang W, Wang X, Zhu C. Erythropoietin Improves Poor Outcomes in Preterm Infants with Intraventricular Hemorrhage. CNS Drugs. 2021 Jun;35(6):681-690. doi: 10.1007/s40263-021-00817-w. Epub 2021 May 6.
- Individual participant dataSharing planned: No
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Changlian Zhu, PhD study chair
Third Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erythropoietin and Normal saline in people with Premature Infants, run by Zhengzhou University 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 5 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 26 Feb 2021. 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. 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?
Mortality (time frame: At corrected age of 18 months). 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 NCT03914690, 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 26 Feb 2021.