Clinical trial NCT02544100: Neonatal Neurologic Intensive Care Network of China
Official title: Neonatal Neurologic Intensive Care Network of China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neonatal Encephalopathy
Suspected Neonatal Encephalopathy
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Xiamen Children's Hospital, Fujian of China
name: Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
name: Guangzhou Women and Children's Medical Center
name: Yuying Children's Hospital of Wenzhou Medical University, Zhejiang of China
name: Maternal and Child Health Hospital of Hubei Province
name: The People's Hospital of Dehong Autonomous Prefecture
name: Guangzhou Medical University
name: Nanfang Hospital, Southern Medical University
First posted: 2015-09-09
Enrollment: 2000
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonatal with severe encephalopathy or suspected severe encephalopathy.

Brief 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.

Detailed description: 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 mainly including demographic, medical history, family condition, perinatal stage information, birth, growth \& feeding status, imaging, 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. There are seven children's hospitals from 6 provinces in China to join in the collaboration network in first recruiting. In addition, the following biological samples will be collected in a bio-bank for future studies: blood, urine, and cerebrospinal fluid (CSF) samples.

Eligibility criteria: Inclusion Criteria:

1. Postnatal age \< or = 28 days
2. Written informed consent of parent or guardian

   With one of the following items
3. Hypoxic ischemic encephalopathy (HIE)
4. Hydrocephalus
5. Hypotonia
6. Interventricular hemorrhages
7. Intracranial calcifications
8. Intracranial hemorrhages
9. Meningitis and other brain infections
10. Metabolic diseases
11. Microcephaly
12. Neonatal stroke
13. Spina bifid
14. Cerebral arteriovenous malformations (AVMs)
15. Congenital brain malformations

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Blood Samples
timeFrame: In 72 hours
measure: Number of Urine Samples
timeFrame: In 72 hours
Secondary outcomes:
measure: Number of Electronic Medical Records
timeFrame: To follow for the duration of hospital stay, an expected average of 4 weeks
measure: Neurodevelopment(Bayley Scores)
timeFrame: At the age of 18 months
measure: Neurological Evaluation(GMFM-88 Scores)
timeFrame: At the age of 18 months
measure: Gene Mutation
timeFrame: At the age of 28 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Wenhao Zhou, Doctor
role: STUDY_CHAIR
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