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

October 11, 2021 updated by: Children's Hospital of Fudan University
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

761

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • The First People's Hospital of Hefei
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Xiamen Women's and Children's Health Centre
      • Zhangzhou, Fujian, China, 363000
        • People's Hospital of Zhangzhou
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • The Second Affiliated Hospital of Guangzhou Medical University
      • Zhongshan, Guangdong, China, 582400
        • Zhongshan Bo Ai Hospital
    • Guizhou
      • Guiyang, Guizhou, China, 550003
        • Maternal and Child Health Hospital of Guiyang Province
    • Hebei
      • Handan, Hebei, China, 056001
        • Handan Central Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • First Hospital of Jilin University
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University
      • Shanghai, Shanghai, China, 201204
        • Shanghai First Maternity and Infant Hospital
    • Shanxi
      • Xian, Shanxi, China, 710061
        • Shanxi Provincial Maternity and Children's Hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • First Affiliated Hospital of Xinjiang Medical University
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Ningbo, Zhejiang, China, 315012
        • Ningbo Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

neonatal intensive-care units

Description

Inclusion Criteria:

  • preterm infants with gestational age less than 32 weeks

Exclusion Criteria:

  • major congenital malformations
  • chromosomal disorders
  • metabolic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
encephalopathy of prematurity
infants with encephalopathy of prematurity showed on MRI at term-equivalent age
no encephalopathy of prematurity
infants with no encephalopathy of prematurity showed on MRI at term-equivalent age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
brain injury showed on MRI
Time Frame: 36-40 weeks' postmenstrual age or before discharge
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
Time Frame: 36-40 weeks' postmenstrual age or before discharge
white matter injury, grey matter injury, cerebellum injury on MRI
36-40 weeks' postmenstrual age or before discharge
all cause mortality
Time Frame: 2 years
Mortality that does not require judgments about the cause of death
2 years
neurodevelopment sequelae
Time Frame: 2 years
including cerebral palsy, epilepsy, hearing loss, vision loss, etc.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

  • Study Director: Chao Chen, PhD, MD, Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

July 10, 2016

First Submitted That Met QC Criteria

July 10, 2016

First Posted (Estimate)

July 13, 2016

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKYYEOPMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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