Clinical trial NCT02831010: A Multi-Center Cohort Study of Risk Factors and Outcomes of Encephalopathy of Prematurity in China
Official title: A Multi-Center Cohort Study of Risk Factors and Outcomes of Encephalopathy of Prematurity in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Encephalopathy
Keywords: prematurity
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 761
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: neonatal intensive-care units

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.

Eligibility criteria: Inclusion Criteria:

* preterm infants with gestational age less than 32 weeks

Exclusion Criteria:

* major congenital malformations
* chromosomal disorders
* metabolic diseases

Primary outcomes:
measure: developmental quotient (DQ) on the Gesell Developmental Schedules
timeFrame: 2 years
Secondary outcomes:
measure: brain injury showed on MRI
timeFrame: 36-40 weeks' postmenstrual age or before discharge
measure: morbidity of encephalopathy of prematurity
timeFrame: 36-40 weeks' postmenstrual age or before discharge
measure: all cause mortality
timeFrame: 2 years
measure: neurodevelopment sequelae
timeFrame: 2 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First People's Hospital of Hefei
state: Anhui
city: Xiamen
country: China
facility: Xiamen Women's and Children's Health Centre
state: Fujian
city: Zhangzhou
country: China
facility: People's Hospital of Zhangzhou
state: Fujian
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan Bo Ai Hospital
state: Guangdong
city: Guiyang
country: China
facility: Maternal and Child Health Hospital of Guiyang Province
state: Guizhou
city: Handan
country: China
facility: Handan Central Hospital
state: Hebei
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
city: Xian
country: China
facility: Shanxi Provincial Maternity and Children's Hospital
state: Shanxi
city: Ürümqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Ningbo
country: China
facility: Ningbo Women's and Children's Hospital
state: Zhejiang
Study officials:
affiliation: Children's Hospital of Fudan University
name: Chao Chen, PhD, MD
role: STUDY_DIRECTOR
References:
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