Neonatal Neurologic Intensive Care Network of China

Study Overview
=================
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.

Official Title
-----------------
Neonatal Neurologic Intensive Care Network of China

Conditions
-----------------
Neonatal Encephalopathy, Suspected Neonatal Encephalopathy

Intervention / Treatment
-----------------
* Other: Database Entry/Biospecimen Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Database Entry / Biospecimen Collection<br>Systematic Medical information of infants born with severe encephalopathy entered into database. In addition, Blood, urine, CFS samples will be collected. | Other: Database Entry/Biospecimen Collection<br>* blood, urine, CFS samples and medical data collected<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Blood Samples | Blood samples-based data of genetic and biomarkers for the monitoring of neonatal encephalopathy. | In 72 hours | 
| Number of Urine Samples | Urine samples-based data of biomarkers for the monitoring of neonatal encephalopathy. | In 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Electronic Medical Records | To collect systemic medical information about neonatal encephalopathy. | To follow for the duration of hospital stay, an expected average of 4 weeks | 
| Neurodevelopment(Bayley Scores) | To evaluate neurodevelopmental function via Bayley Scores of Infant Development Mental Development Index (BSIDMI) and gain incidence of BSIMDI<70(Severe) or BSIMDI<85(Moderate). | At the age of 18 months | 
| Neurological Evaluation(GMFM-88 Scores) | To gain changes in standardized gross motor function using GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales, lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0 100 , Higher value means better gross motor function). | At the age of 18 months | 
| Gene Mutation | To detect the mutation and characterize the genetic architecture and risk variants of neonatal malformation using different genomic methods. | At the age of 28 days |