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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02831010
Enrollment
761
Registered
2016-07-13
Start date
2014-04-30
Completion date
2020-12-31
Last updated
2021-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalopathy

Keywords

prematurity

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.

Interventions

None listed

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No

Inclusion criteria

* preterm infants with gestational age less than 32 weeks

Exclusion criteria

* major congenital malformations * chromosomal disorders * metabolic diseases

Design outcomes

Primary

MeasureTime frameDescription
developmental quotient (DQ) on the Gesell Developmental Schedules2 yearsResult of gross motor, fine motor, language and social test. DQ = Development Age / Chronological Age X 100

Secondary

MeasureTime frameDescription
brain injury showed on MRI36-40 weeks' postmenstrual age or before dischargesignal abnormality in white matter, grey matter or cerebellum injury; periventricular leukomalacia; intracranial hemorrhage
morbidity of encephalopathy of prematurity36-40 weeks' postmenstrual age or before dischargewhite matter injury, grey matter injury, cerebellum injury on MRI
all cause mortality2 yearsMortality that does not require judgments about the cause of death
neurodevelopment sequelae2 yearsincluding cerebral palsy, epilepsy, hearing loss, vision loss, etc.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026