RecruitingNCT02544100

Neonatal Neurologic Intensive Care Network of China


Sponsor

Children's Hospital of Fudan University

Enrollment

2,000 participants

Start Date

Sep 1, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to create a neonatal neurologic biological big data center named Neonatal Neurologic Intensive Care Network in China with neonatal systematic information, biological samples and genomics \& genetic data on neonates born with neonatal severe encephalopathy. It also can predict brain injury as cerebral function monitoring through big data and recommend appropriate treatment. In addition, the following samples will be collected in a bio-bank in for future studies: blood, urine, and cerebrospinal fluid (CSF) samples.


Eligibility

Max Age: 28 Days

Inclusion Criteria16

  • Postnatal age \< or = 28 days
  • Written informed consent of parent or guardian
  • With one of the following items
  • Hypoxic ischemic encephalopathy (HIE)
  • Hydrocephalus
  • Hypotonia
  • Interventricular hemorrhages
  • Intracranial calcifications
  • Intracranial hemorrhages
  • Meningitis and other brain infections
  • Metabolic diseases
  • Microcephaly
  • Neonatal stroke
  • Spina bifid
  • Cerebral arteriovenous malformations (AVMs)
  • Congenital brain malformations

Exclusion Criteria3

  • Known other major congenital anomalies but not not neurologic disease.
  • Failed to get sample or the volume of collected biosamples is not enough.
  • Parents refuse consent.

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Interventions

OTHERDatabase Entry/Biospecimen Collection

blood, urine, CFS samples and medical data collected


Locations(1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, China

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NCT02544100


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