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Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage

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ClinicalTrials.gov Identifier: NCT03914690
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Zhengzhou Children's Hospital, China
Göteborg University
Information provided by (Responsible Party):
Changlian Zhu, Third Affiliated Hospital of Zhengzhou University

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Premature Infants Drug: Erythropoietin Drug: Normal saline Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage
Actual Study Start Date : July 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Erythropoietin
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.
Drug: Erythropoietin
EPO is administered 500IU/kg, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks.
Other Name: Epoietin Beta

Placebo Comparator: Normal saline
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.
Drug: Normal saline
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Incidence of cerebral palsy [ Time Frame: At corrected age of 18 months ]
    To compare the incidence of cerebral palsy in EPO treatment and control groups at 18 months of corrected age.

  2. Incidence of MDI<70 [ Time Frame: At corrected age of 18 months ]
    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.

  3. Incidence of blindness [ Time Frame: At corrected age of 18 months ]
    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.

  4. Incidence of deafness [ Time Frame: At corrected age of 18 months ]
    To compare the incidence of deafness via auditory brainstem response measurements in EPO treatment and control groups at 18 months of corrected age.

  5. The effect of EPO treatment on blood mRNA expression [ Time Frame: At 3 weeks after birth ]
    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.



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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914690


Contacts
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Contact: Changlian Zhu, PhD +8637166903974 zhuc@zzu.edu.cn
Contact: Juan Song, PhD +8637166903974 songjuan@zzu.edu.cn

Locations
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China, Henan
Third Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Changlian Zhu, PhD    +8637166903974    zhuc@zzu.edu.cn   
Sponsors and Collaborators
Zhengzhou University
Zhengzhou Children's Hospital, China
Göteborg University
Investigators
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Study Chair: Changlian Zhu, PhD Third Affiliated Hospital of Zhengzhou University
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Responsible Party: Changlian Zhu, Director, Clinical research center, Third Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT03914690    
Other Study ID Numbers: EPO2014
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Epoetin Alfa
Hematinics