The neurocritical care research network: NCRN.
J I Suarez, R Geocadin, C Hall...
https://pubmed.ncbi.nlm.nih.gov/21792751Actively Recruiting
Age: 0 - 28Days
All Genders
ID02544100
Neonatal Neurologic Intensive Care Network of China
Led by Children's Hospital of Fudan University · Updated on 2025-09-05
2000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Children's Hospital of Fudan University
Lead Sponsor
X
Xiamen Children's Hospital, Fujian of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are creating a Neonatal Neurologic Intensive Care Network in China to collect and analyze large-scale data on newborns with severe encephalopathy. This network gathers detailed neonatal information including demographics, medical history, family background, perinatal details, birth, growth, feeding status, imaging, biological samples, and genetic data. The goal is to use big data to monitor brain function, predict brain injuries, and suggest appropriate treatments. Seven children's hospitals from six provinces in China are participating in this collaborative effort. Participants in this observational study will have their systematic medical information entered into a comprehensive database. Biological samples such as blood, urine, and cerebrospinal fluid (CSF) will be collected and stored in a biobank for future research. This sample collection occurs within 72 hours after birth. The study involves continuous follow-up during the hospital stay, with an expected average duration of about four weeks. During the study, electronic medical records will be monitored for the hospital stay duration. Neurodevelopmental outcomes will be assessed using Bayley Scores and neurological evaluations with GMFM-88 Scores at 18 months of age. Gene mutation analysis will be conducted at 28 days. The study will track the number of blood and urine samples collected within the first 72 hours and record various clinical and biological data to support ongoing and future research in neonatal brain injury and care.
CONDITIONS
Brief Title
Neonatal Neurologic Intensive Care Network of China
Who Can Participate
Age: 0 - 28Days
All Genders
Eligibility Criteria
You may qualify if you...
- Postnatal age 28 days or younger
- Written informed consent of parent or guardian
- Diagnosis of one or more of the following: hypoxic ischemic encephalopathy (HIE), hydrocephalus, hypotonia, interventricular hemorrhages, intracranial calcifications, intracranial hemorrhages, meningitis or other brain infections, metabolic diseases, microcephaly, neonatal stroke, spina bifida, cerebral arteriovenous malformations (AVMs), or congenital brain malformations
You will not qualify if you...
- Known major congenital anomalies not related to neurologic disease
- Unable to obtain sufficient biosample volume or sample collection failed
- Parents refuse to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Observational Monitoring
Duration - Approximately 4 weeks during hospital stay
Participants with neonatal severe encephalopathy have systematic medical information collected and biological samples (blood, urine, cerebrospinal fluid) gathered for research purposes.
Multiple visits during hospital stay
Long-term Monitoring
Duration - Up to 18 months
Participants' neurodevelopment and neurological status are assessed at 18 months of age, and gene mutation analysis is completed by 28 days.
Assessments at 28 days and 18 months
Trial Site Locations
Total: 1 location
1
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
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Research Team
W
Wenhao Zhou, Doctor
G
Guoqiang Cheng, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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