Neonatal Encephalopathy, Suspected Neonatal Encephalopathy
Conditions
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.
Interventions
blood, urine, CFS samples and medical data collected
Sponsors
Xiamen Children's Hospital, Fujian of China
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Guangzhou Women and Children's Medical Center
Yuying Children's Hospital of Wenzhou Medical University, Zhejiang of China
Maternal and Child Health Hospital of Hubei Province
The People's Hospital of Dehong Autonomous Prefecture
Guangzhou Medical University
Nanfang Hospital, Southern Medical University
Children's Hospital of Fudan University
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Blood Samples | In 72 hours | Blood samples-based data of genetic and biomarkers for the monitoring of neonatal encephalopathy. |
| Number of Urine Samples | In 72 hours | Urine samples-based data of biomarkers for the monitoring of neonatal encephalopathy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Electronic Medical Records | To follow for the duration of hospital stay, an expected average of 4 weeks | To collect systemic medical information about neonatal encephalopathy. |
| Neurodevelopment(Bayley Scores) | At the age of 18 months | 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). |
| Neurological Evaluation(GMFM-88 Scores) | At the age of 18 months | 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). |
| Gene Mutation | At the age of 28 days | To detect the mutation and characterize the genetic architecture and risk variants of neonatal malformation using different genomic methods. |
Countries
China
Contacts
Primary ContactWenhao Zhou, Doctor
Backup ContactGuoqiang Cheng, Doctor
Outcome results
None listed