Neonatal Neurologic Intensive Care Network of China

Fudan University

Status: Enrolling

Conditions: Neonatal Encephalopathy; Suspected Neonatal Encephalopathy

Treatments: Other: Database Entry/Biospecimen Collection

Study type: Observational

Funder types: Other

Identifiers

NCT02544100

CHFudanU_NNICU5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 1 patient group

Database Entry / Biospecimen Collection

Description:

Systematic Medical information of infants born with severe encephalopathy entered into database. In addition, Blood, urine, CFS samples will be collected.

Treatment:

Other: Database Entry/Biospecimen Collection