ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02831010
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

July 10, 2016
July 13, 2016
September 20, 2017
April 2014
December 2018   (Final data collection date for primary outcome measure)
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
neurodevelopmental outcome [ Time Frame: two years ]
Complete list of historical versions of study NCT02831010 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • all cause mortality [ Time Frame: 2 years ]
  • neurodevelopment sequelae [ Time Frame: 2 years ]
    including cerebral palsy, epilepsy, hearing loss, vision loss, etc.
Not Provided
Not Provided
Not Provided
 
A Multi-Center Cohort Study of Risk Factors and Outcomes of Encephalopathy of Prematurity in China
A Multi-Center Cohort Study of Risk Factors and Outcomes of Encephalopathy of Prematurity in China
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
serum, tissue
Non-Probability Sample
neonatal intensive-care units
Encephalopathy
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • preterm infants with gestational age <32 weeks

Exclusion Criteria:

  • major congenital malformations
  • chromosomal disorders
  • metabolic diseases
Sexes Eligible for Study: All
up to 28 Days   (Child)
No
Contact: Chao Chen, Phd, MD chen6010@163.com
China
 
 
NCT02831010
EKYYEOPMC
No
Not Provided
Plan to Share IPD: Undecided
Children's Hospital of Fudan University
Children's Hospital of Fudan University
Not Provided
Study Director: Chao Chen, PhD, MD Children's Hospital of Fudan University
Children's Hospital of Fudan University
September 2017