Creating a neonatal neurologic data center in China
Official title: Neonatal Neurologic Intensive Care Network of China
Run by Children's Hospital of Fudan University · NCT02544100 · Data updated 2026-11-12
This study is setting up a network in China to gather important health information and samples from newborns with severe brain issues to help doctors predict problems and find better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 28 Days |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | September 1, 2015 |
| Main results expected | December 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | September 5, 2025 |
| Trial ID | NCT02544100 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are neonates aged 28 days or younger with conditions such as hypoxic ischemic encephalopathy, hydrocephalus, or other specified neurological disorders.
✕Probably not a fit
Patients with known major congenital anomalies unrelated to neurological diseases or those whose parents refuse consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to establish the Neonatal Neurologic Intensive Care Network in China, which will compile a comprehensive database of neonatal information, biological samples, and genetic data for infants diagnosed with severe neonatal encephalopathy. The network will facilitate the prediction of brain injuries through cerebral function monitoring and recommend appropriate treatments based on big data analysis. Participating hospitals will collect various biological samples, including blood, urine, and cerebrospinal fluid, to support future research. The initiative involves collaboration among seven children's hospitals across six provinces in China.
Why it matters
Potential benefit: If successful, this initiative could significantly enhance the understanding and treatment of neonatal encephalopathy, leading to improved outcomes for affected infants.
How similar studies have gone: While the approach of creating a comprehensive neonatal data network is innovative, similar studies have shown promise in utilizing big data for predicting and managing neonatal conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Wenhao Zhou, Doctor
- Email: zwhchfu@126.com
Similar studies
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Genetic causes of neonatal encephalopathy and related conditions
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.