Clinical Trials Directory

Trials / Completed

CompletedNCT02831010

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

Status
Completed
Phase
Study type
Observational
Enrollment
761 (actual)
Sponsor
Children's Hospital of Fudan University · Academic / Other
Sex
All
Age
28 Days
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2014-04-01
Primary completion
2019-12-01
Completion
2020-12-01
First posted
2016-07-13
Last updated
2021-10-12

Locations

14 sites across 1 country: China

Source: ClinicalTrials.gov record NCT02831010. Inclusion in this directory is not an endorsement.

A Multi-Center Cohort Study of Risk Factors and Outcomes of Encephalopathy of Prematurity in China (NCT02831010) · Clinical Trials Directory