Erythropoietin in Premature Infants to Prevent Encephalopathy

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    312
  • sponsor
    Children's Hospital of Fudan University
Updated on 22 January 2022

Summary

The main goal of this trial is to investigate whether early administration of human erythropoietin (EPO) in preterm infants improves neurodevelopmental outcome at 18 months corrected age. This study is designed as randomized, double-masked, placebo controlled multicenter study involving at least 312 patients.

Description

EPO has been safely used for prevent preterm anemia and recent studies have shown the neuro-protective effect. Our hypothesis is that EPO could prevent preterm brain injury and reduce the rate of premature death and disability from encephalopathy. The aims of this study include: to investigate the safety and efficacy of EPO by using 1000u/kg higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on neurodevelopment in preterm infants; to detect biological and imaging indicators of EPO. Eligible premature infants will be enrolled in this double-blind, placebo-controlled randomized trial from the neonatal neurological intensive care unit (NNICU) at 7 Children's Hospital in 6 provinces of China. Subjects will be enrolled within the first 24 hours of life and randomly assigned to receive Epo or saline vehicle placebo. Standard NICU care will be provided to all subjects. Pharmacokinetic data, serial brain electrophysiologic and imaging exams, circulating inflammatory mediators, biomarkers and complications like polycythemia, neutropenia, thrombocytopenia, hypertension, sepsis, hemorrhage, seizure, necrotizing enterocolitis (NEC), persistent ductus arterious (PDA), apnea of prematurity, pulmonary haemorrhage, pulmonary hypertension, Prolonged blood coagulation time, retinopathy of prematurity (ROP), cardiac arrhythmia, major venous thrombosis, Renal failure treated with dialysis, pneumonia, pulmonary airleak and chronic lung disease will be collected at established time points during the study period. At 18 months corrected age, subjects will undergo a neurodevelopmental evaluation assessing for cerebral palsy, Bayley Scores of Mental Development Index (MDI) use.

Details
Condition Premature Infant
Treatment Epo, Epo, Normal saline
Clinical Study IdentifierNCT02550054
SponsorChildren's Hospital of Fudan University
Last Modified on22 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Birthweight less or equal 1500 grams
Less than 32 weeks gestation at birth
Less than 48 hours of life at time of enrollment
Written informed consent of parent or guardian

Exclusion Criteria

Intrauterine Growth Retardation
Severe Congenital Anomalies adversely affecting life expectancy or neurodevelopment
Genetic Metabolic Diseases
Seizures within first 24 hours of life
Severe neutropenia (ANC < 500 cells/microL) within first 24 hours of life
Polycythemia (Hct > 65%) within first 24 hours of life
Thrombocytopenia (platelets < 50K cells/microL) within first 24 hours of life
Hypertension (SBP > 100mmHg) without vasopressor support within first 24 hours of life
Microcephaly
Grade III-IV intracranial hemorrhage
Termination
Required by parent or guardian
Polycythemia through blood transfusion can not be relieved
Oliguria<0.5mL/kg/h for at least 24 hours
Progression of azotemia
Pulmonary hypertension or Cardiac arrhythmia
Clear my responses

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