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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Encephalopathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preterm infants with gestational age less than 32 weeks Exclusion Criteria: major congenital malformations chromosomal disorders metabolic diseases

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| encephalopathy of prematurity<br>infants with encephalopathy of prematurity showed on MRI at term-equivalent age | |
| no encephalopathy of prematurity<br>infants with no encephalopathy of prematurity showed on MRI at term-equivalent age | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| developmental quotient (DQ) on the Gesell Developmental Schedules | Result of gross motor, fine motor, language and social test. DQ = Development Age / Chronological Age X 100 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain injury showed on MRI | signal abnormality in white matter, grey matter or cerebellum injury; periventricular leukomalacia; intracranial hemorrhage | 36-40 weeks' postmenstrual age or before discharge | 
| morbidity of encephalopathy of prematurity | white matter injury, grey matter injury, cerebellum injury on MRI | 36-40 weeks' postmenstrual age or before discharge | 
| all cause mortality | Mortality that does not require judgments about the cause of death | 2 years | 
| neurodevelopment sequelae | including cerebral palsy, epilepsy, hearing loss, vision loss, etc. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prematurity