Effect of Erythropoietin in Premature Infants on White Matter Lesions and Neurodevelopmental Outcome

Summary

Preterm and very preterm infants are at risk of developing encephalopathy of prematurity and long-term neurodevelopmental delay. Magnetic resonance imaging (MRI) allows the characterization of specific features of encephalopathy of prematurity, including structural changes of brain white matter and gray matter. This study wants to investigate important evidence that early repeated high-dose rhEPO(5250 IU/kg) treatment improves long-term neurological outcomes in very preterm infants and without obvious adverse effects.

Conditions

• Premature Infants
• Intracranial Hemorrhages
• Periventricular Leukomalacia
• Cerebral Palsy

Interventions

DRUG

Erythropoietin

rhEPO 750U/kg was injected within 72h after birth, subsequent injection was given every other day for 2 weeks (a cumulative dose of 5,250U/kg over the course of 7 separate intravenous injections.

DRUG

Normal saline

placebo (Normal saline 3 ml/kg birth weight) was injected within 72h after birth, subsequent injection was given every other day for 2 weeks.

Sponsors & Collaborators

• Xian Children's Hospital

  collaborator OTHER_GOV

• Shaanxi Provincial People's Hospital

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• Xi'an No.4 Hospital

  collaborator UNKNOWN

• Northwest Women's and Children's Hospital, Xi'an, Shaanxi

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  lead OTHER

Principal Investigators

• Xihui Zhou, Doctor · First Affiliated Hospital of Xian JiaotongUniversity

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Max Age

3 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-10

Primary Completion

2018-12-31

Completion

2019-06-30

Countries

• China

Study Locations