Neonatal Neurologic Intensive Care Network of China
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- Number of Blood Samples
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- — to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
Number of Blood Samples
Time Frame: In 72 hours
Blood samples-based data of genetic and biomarkers for the monitoring of neonatal encephalopathy.
Number of Urine Samples
Time Frame: In 72 hours
Urine samples-based data of biomarkers for the monitoring of neonatal encephalopathy.
Secondary Outcomes
- Number of Electronic Medical Records(To follow for the duration of hospital stay, an expected average of 4 weeks)
- Gene Mutation(At the age of 28 days)
- Neurodevelopment(Bayley Scores)(At the age of 18 months)
- Neurological Evaluation(GMFM-88 Scores)(At the age of 18 months)