Premature InfantPhase 2NCT03919500
Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis
A Phase 2 study testing EPO and Normal saline in people with Premature Infant, run by Zhengzhou University at 1 site in China.
Trial summary
This study evaluates the effect of repeated low-dose erythropoietin (EPO) treatment on necrotizing enterocolitis (NEC) in very preterm infants. Half of participants will receive EPO, while the other half will receive a placebo. Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Premature Infant
- What is being tested?
- EPO and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,285 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Apr 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 with gestation age ≤ 32weeks
- Within 72 hours after birth
- Written informed consent obtained from parents
Who cannot join
- Genetic or metabolic diseases
- Congenital abnormalities
- Polycythemia
- Intracranial hemorrhage grade III/IV
- 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
This study evaluates the effect of repeated low-dose erythropoietin (EPO) treatment on necrotizing enterocolitis (NEC) in very preterm infants. Half of participants will receive EPO, while the other half will receive a placebo.
Read the detailed description
NEC is one of the most severe complications in preterm neonates and is associated with high morbility and mortality. Studies have reported that EPO treatment decreases the incidence and severity of experimental NEC in animal models. Evidence from previous clinical studies about the effect of EPO treatment against NEC have all been hampered by small numbers of patients. The study is to investigate whether repeated low-dose EPO protects against NEC. Preterm infants with gestational age ≤32 weeks who are admitted to neonatal intensive care units within 72 hours after birth are randomized to EPO (500IU/kg, intravenously every other day for 2 weeks) or control group (the same volume of saline). Primary outcome is the incidence of NEC at 36 weeks of corrected age. Secondary outcome is growth and neurodevelopment at 18 months of corrected age in infants with NEC.
- Conditions
- Premature Infant
- Being tested
- EPO, Normal saline
- Keywords
- Preterm infant, Necrotizing enterocolitis, Erythropoietin, Neurodevelopment
- Medical subject headings
- Premature Birth, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPODrug
Also called Epoetin Beta
Infants in EPO group are administered 500IU/kg intravenously within 72 hours after birth every other day for 2 weeks.
Normal salineDrug
Infants in control group are administered normal saline with the same volume and period as EPO.
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin | Experimental | Infants in the EPO group are given EPO 500IU/kg dissolved in 2 ml saline intravenously every other day for 2 weeks starting within 72 hours after birth. Receives: Drug: EPO |
| Normal saline | Placebo comparator | Infants in the control group are given normal saline intravenously with the same volume as EPO 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.
Incidence of NEC
To compare the incidence of NEC between EPO group and control group at 36 weeks of corrected age
Measured: At 36 weeks of corrected age
Secondary outcomes (8)
Incidence of low height in patients with NEC
To compare the incidence of low height in patients with NEC between EPO and control groups via the Standardized Growth Curve for Chinese Children at 18 months of corrected age.
Measured: At corrected age of 18 months
Incidence of low weight in patients with NEC
To compare the incidence of low weight in patients with NEC between EPO and control group via the Standardized Growth Curve for Chinese Children at 18 months of corrected age.
Measured: At corrected age of 18 months
Incidence of low head circumference in patients with NEC
To compare the incidence of low head circumference in patients with NEC between EPO and control group via the Standardized Growth Curve for Chinese Children at 18 months of corrected age.
Measured: At corrected age of 18 months
Incidence of MDI<70 in patients with NEC
To compare the incidence of MDI<70 in patients with NEC between EPO and control group via Bayley Scales of Infant Development (second edition) at 18 months of corrected age.
Measured: At corrected age of 18 months
Incidence of cerebral palsy in patients with NEC
To compare the incidence of cerebral palsy in patients with NEC between EPO and control group at 18 months of corrected age.
Measured: At corrected age of 18 months
Incidence of blindness in patients with NEC
To compare the incidence of blindness in patients with NEC between EPO and control group via visual acuity at 18 months of corrected age.
Measured: At corrected age of 18 months
Incidence of deafness in patients with NEC
To compare the incidence of deafness in patients with NEC between EPO and control group via auditory brainstem response measurement at 18 months of corrected age.
Measured: At corrected age of 18 months
The effect of EPO treatment on blood messenger RNA (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 posted18 Apr 2019
- Study startJan 2014
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies 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
- 1,285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhengzhou Children's Hospital, China, The First Affiliated Hospital of Zhengzhou University, Women and Children Health Care Center of Luoyang, China, Göteborg University
- Responsible party
- Principal investigator, Changlian Zhu, Zhengzhou University
- Investigators
- Changlian Zhu, PhD, Study chair, Third Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919500
- Sponsor's protocol ID
- HN-2014002
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
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 33076939Wang Y, Song J, Sun H, Xu F, Li K, Nie C, Zhang X, Peng X, Xia L, Shen Z, Yuan X, Zhang S, Ding X, Zhang Y, Kang W, Qian L, Zhou W, Wang X, Cheng X, Zhu C. Erythropoietin prevents necrotizing enterocolitis in very preterm infants: a randomized controlled trial. J Transl Med. 2020 Aug 8;18(1):308. doi: 10.1186/s12967-020-02459-w.
PubMed 32771013
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis
- ClinicalTrials.gov ID
- NCT03919500
- Acronym / sponsor ID
- HN-2014002
- Conditions
- Premature Infant
- Keywords
- Preterm infant, Necrotizing enterocolitis, Erythropoietin, Neurodevelopment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,285 participants (actual)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Zhengzhou Children's Hospital, China, The First Affiliated Hospital of Zhengzhou University, Women and Children Health Care Center of Luoyang, China, Göteborg University
- Study start
- Jan 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 18 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.
This study evaluates the effect of repeated low-dose erythropoietin (EPO) treatment on necrotizing enterocolitis (NEC) in very preterm infants. Half of participants will receive EPO, while the other half will receive a placebo.
Detailed description
NEC is one of the most severe complications in preterm neonates and is associated with high morbility and mortality. Studies have reported that EPO treatment decreases the incidence and severity of experimental NEC in animal models. Evidence from previous clinical studies about the effect of EPO treatment against NEC have all been hampered by small numbers of patients. The study is to investigate whether repeated low-dose EPO protects against NEC. Preterm infants with gestational age ≤32 weeks who are admitted to neonatal intensive care units within 72 hours after birth are randomized to EPO (500IU/kg, intravenously every other day for 2 weeks) or control group (the same volume of saline). Primary outcome is the incidence of NEC at 36 weeks of corrected age. Secondary outcome is growth and neurodevelopment at 18 months of corrected age in infants with NEC.
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: EPOInfants in the EPO group are given EPO 500IU/kg dissolved in 2 ml saline intravenously every other day for 2 weeks starting within 72 hours after birth. |
| Normal saline | Placebo comparator | Drug: Normal salineInfants in the control group are given normal saline intravenously with the same volume as EPO 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 (3 listed)
- Preterm infants with gestation age ≤ 32weeks
- Within 72 hours after birth
- Written informed consent obtained from parents
Key exclusion criteria (5 listed)
- Genetic or metabolic diseases
- Congenital abnormalities
- Polycythemia
- Intracranial hemorrhage grade III/IV
- 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 |
|---|---|---|
| EPOAlso: Epoetin BetaInfants in EPO group are administered 500IU/kg intravenously within 72 hours after birth every other day for 2 weeks. | Drug | Erythropoietin |
| Normal salineInfants in control group are administered normal saline with the same volume and period as EPO. | Drug | Normal saline |
Primary outcome
Incidence of NEC
Time frame: At 36 weeks of corrected age
To compare the incidence of NEC between EPO group and control group at 36 weeks of corrected age
8 secondary outcomes
Incidence of low height in patients with NEC
Time frame: At corrected age of 18 months
Incidence of low weight in patients with NEC
Time frame: At corrected age of 18 months
Incidence of low head circumference in patients with NEC
Time frame: At corrected age of 18 months
Incidence of MDI<70 in patients with NEC
Time frame: At corrected age of 18 months
Incidence of cerebral palsy in patients with NEC
Time frame: At corrected age of 18 months
Incidence of blindness in patients with NEC
Time frame: At corrected age of 18 months
Incidence of deafness in patients with NEC
Time frame: At corrected age of 18 months
The effect of EPO treatment on blood messenger RNA (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 19 Apr 2019.
- 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.
- Derived from this study: PubMed 32771013Wang Y, Song J, Sun H, Xu F, Li K, Nie C, Zhang X, Peng X, Xia L, Shen Z, Yuan X, Zhang S, Ding X, Zhang Y, Kang W, Qian L, Zhou W, Wang X, Cheng X, Zhu C. Erythropoietin prevents necrotizing enterocolitis in very preterm infants: a randomized controlled trial. J Transl Med. 2020 Aug 8;18(1):308. doi: 10.1186/s12967-020-02459-w.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
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 EPO and Normal saline in people with Premature Infant, 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 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 19 Apr 2019. 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?
Incidence of NEC (time frame: At 36 weeks of corrected age). 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 NCT03919500, which also lists 2 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 19 Apr 2019.