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A Multi-Center Cohort Study of Risk Factors and Outcomes of Encephalopathy of Prematurity in China

Fudan University logo

Fudan University

Status

Completed

Conditions

Encephalopathy

Study type

Observational

Funder types

Other

Identifiers

NCT02831010
EKYYEOPMC

Details and patient eligibility

About

The purpose of this study is to explore the perinatal risk factors of encephalopathy of prematurity and the morbidity of the following neurodevelopmental impairments in preterm infants with gestational age <32 weeks in China.

Full description

Recent years have witnessed an increase in survival of very or extremely low birth weight infants, with a corresponding increase of attention to encephalopathy of prematurity (EOP) and the following neurological disorders. Studies suggested that hypoxic-ischemic injury and perinatal infection might be the two main risk factors of EOP, including white matter injury, neuronal-axonal diseases and cerebellar hemorrhage, which have a strong impact on neurological outcomes. Sequelae like cerebral palsy or mental retardation become a burden to both the family and society. Therefore, the risk factors of brain injury become the critical issue of both Obstetrics and Neonatology. More importantly, little is known about the morbidity of neurodevelopmental impairment and its risk factors in China. Thus, the aim of our study is to explore the perinatal risk factors of encephalopathy of prematurity and the morbidity of the following neurodevelopmental impairments in preterm infants with gestational age <32 weeks in China.

Enrollment

761 patients

Sex

All

Ages

Under 28 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • preterm infants with gestational age less than 32 weeks

Exclusion criteria

  • major congenital malformations
  • chromosomal disorders
  • metabolic diseases

Trial design

761 participants in 2 patient groups

encephalopathy of prematurity
Description:
infants with encephalopathy of prematurity showed on MRI at term-equivalent age
no encephalopathy of prematurity
Description:
infants with no encephalopathy of prematurity showed on MRI at term-equivalent age

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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