The practice of pediatric neurocritical care by the child neurologist.
James J Riviello, Cherylee Chang
https://pubmed.ncbi.nlm.nih.gov/25727512/Actively Recruiting
Led by Children's Hospital of Fudan University · Updated on 2025-09-05
2000
Participants Needed
1
Research Sites
N/A
Total Duration
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 childrens 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
Neonatal Neurologic Intensive Care Network of China
W
Wenhao Zhou, Doctor
G
Guoqiang Cheng, Doctor
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Children's Hospital of Fudan University
Lead Sponsor
Xiamen Children's Hospital, Fujian of China
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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James J Riviello, Cherylee Chang
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https://pubmed.ncbi.nlm.nih.gov/25727504/Children's Hospital of Fudan University
Lead Sponsor
Xiamen Children's Hospital, Fujian of China
Collaborating Sponsor