Neonatal Neurologic Intensive Care Network of China

NCT02544100 · tracked via the Priya Life Science China tracker

Sponsor

Children's Hospital of Fudan University

Phase

Observational

Started

2015-09-01

Last updated

2025-09-05

Condition(s) studied

Neonatal EncephalopathySuspected Neonatal Encephalopathy

Investigational drug(s) / intervention(s)

Database Entry/Biospecimen Collection

Database Entry/Biospecimen Collection: blood, urine, CFS samples and medical data collected

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

28 Days

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Children Hospital of Fudan University	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02544100 on ClinicalTrials.gov ↗ ← All trials in China