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NCT Number: NCT02831010

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.

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Key information

Conditions

Encephalopathy Brain Diseases Central Nervous System Diseases Female Urogenital Diseases and Pregnancy Complications Nervous System Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

The First People's Hospital of Hefei, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • preterm infants with gestational age less than 32 weeks

Exclusion criteria

  • major congenital malformations
  • chromosomal disorders
  • metabolic diseases

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Jul 13, 2016
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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