A Multi-Center Cohort Study of Risk Factors and Outcomes of Encephalopathy of Prematurity in China
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 761
- Locations
- 14
- Primary Endpoint
- developmental quotient (DQ) on the Gesell Developmental Schedules
Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •preterm infants with gestational age less than 32 weeks
Exclusion Criteria
- •major congenital malformations
- •chromosomal disorders
- •metabolic diseases
Outcomes
Primary Outcomes
developmental quotient (DQ) on the Gesell Developmental Schedules
Time Frame: 2 years
Result of gross motor, fine motor, language and social test. DQ = Development Age / Chronological Age X 100
Secondary Outcomes
- brain injury showed on MRI(36-40 weeks' postmenstrual age or before discharge)
- all cause mortality(2 years)
- morbidity of encephalopathy of prematurity(36-40 weeks' postmenstrual age or before discharge)
- neurodevelopment sequelae(2 years)