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

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ClinicalTrials.gov Identifier: NCT02831010
Recruitment Status : Active, not recruiting
First Posted : July 13, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Encephalopathy

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
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Center Cohort Study of Risk Factors and Outcomes of Encephalopathy of Prematurity in China
Study Start Date : April 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. all cause mortality [ Time Frame: 2 years ]
    Mortality that does not require judgments about the cause of death

  4. neurodevelopment sequelae [ Time Frame: 2 years ]
    including cerebral palsy, epilepsy, hearing loss, vision loss, etc.


Biospecimen Retention:   Samples Without DNA
serum, tissue


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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
neonatal intensive-care units
Criteria

Inclusion Criteria:

  • preterm infants with gestational age less than 32 weeks

Exclusion Criteria:

  • major congenital malformations
  • chromosomal disorders
  • metabolic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831010


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

Publications:

Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT02831010     History of Changes
Other Study ID Numbers: EKYYEOPMC
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Children's Hospital of Fudan University:
prematurity

Additional relevant MeSH terms:
Brain Diseases
Premature Birth
Central Nervous System Diseases
Nervous System Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications