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

Completed

• Conditions: Encephalopathy

• Registration Number: NCT02831010
• Lead Sponsor: Children's Hospital of Fudan University

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-07-10
• Study First Submitted QC: 2016-07-10
• Study First Posted: 2016-07-13
• Primary Completion: 2019-12
• Study Completion: 2020-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-11
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 761

Inclusion Criteria

• preterm infants with gestational age less than 32 weeks

Exclusion Criteria

• major congenital malformations
• chromosomal disorders
• metabolic diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
developmental quotient (DQ) on the Gesell Developmental Schedules	2 years	Result of gross motor, fine motor, language and social test. DQ = Development Age / Chronological Age X 100

Secondary Outcome Measures

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

Trial Locations

Locations (14)

The First People's Hospital of Hefei; 🇨🇳 Hefei, Anhui, China

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Xiamen Women's and Children's Health Centre; 🇨🇳 Xiamen, Fujian, China

People's Hospital of Zhangzhou; 🇨🇳 Zhangzhou, Fujian, China

Zhongshan Bo Ai Hospital; 🇨🇳 Zhongshan, Guangdong, China

Maternal and Child Health Hospital of Guiyang Province; 🇨🇳 Guiyang, Guizhou, China

Ningbo Women's and Children's Hospital; 🇨🇳 Ningbo, Zhejiang, China

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Handan Central Hospital; 🇨🇳 Handan, Hebei, China

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Shanghai First Maternity and Infant Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanxi Provincial Maternity and Children's Hospital; 🇨🇳 Xian, Shanxi, China

First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Ürümqi, Xinjiang, China

First Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China