NCT03914690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

5 years

First QC Date

April 11, 2019

Last Update Submit

February 25, 2021

Conditions

Premature Infants

Outcome Measures

Primary Outcomes (2)

  • Mortality

    To compare the death rate in EPO treatment and control groups at 18 months of corrected age.

    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.

    At corrected age of 18 months

Secondary Outcomes (5)

  • Incidence of cerebral palsy

    At corrected age of 18 months

  • Incidence of MDI<70

    At corrected age of 18 months

  • Incidence of blindness

    At corrected age of 18 months

  • Incidence of deafness

    At corrected age of 18 months

  • The effect of EPO treatment on blood mRNA expression

    At 3 weeks after birth

Study Arms (2)

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.

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.

Drug: Normal saline

Interventions

ErythropoietinDRUG

EPO is administered 500IU/kg, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks.

Also known as: Epoietin Beta
Erythropoietin
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.

Normal saline

Eligibility Criteria

AgeUp to 72 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Related Publications (1)

  • 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.

    PMID: 33959935DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

ErythropoietinSaline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Changlian Zhu, PhD

    Third Affiliated Hospital of Zhengzhou University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical research center

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 16, 2019

Study Start

July 1, 2014

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

February 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)