NCT02544100 Neonatal Neurologic Intensive Care Network of China
| NCT ID | NCT02544100 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Neonatal Encephalopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2015-09-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2015-09-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Wenhao Zhou, Doctor
✉ zwhchfu@126.comWenhao Zhou, Doctor
STUDY CHAIR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT02544100 clinical trial?
This trial is open to participants of all sexes, up to 28 Days, studying Neonatal Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02544100 currently recruiting?
Yes, NCT02544100 is actively recruiting participants. Contact the research team at zwhchfu@126.com for enrollment information.
Where is the NCT02544100 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT02544100 clinical trial?
NCT02544100 is sponsored by Children's Hospital of Fudan University. The principal investigator is Wenhao Zhou, Doctor at Children's Hospital of Fudan University. The trial plans to enroll 2,000 participants.