Neonatal Neurologic Intensive Care Network of China
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 28
SponsorChildren's Hospital of Fudan University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Postnatal age < or = 28 days
Written informed consent of parent or guardian
Hypoxic ischemic encephalopathy (HIE)
Hydrocephalus
Disqualifiers
Known other major congenital anomalies but not not neurologic disease.
Failed to get sample or the volume of collected biosamples is not enough.
Parents refuse consent.
Trial population
Neonatal with severe encephalopathy or suspected severe encephalopathy.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Database Entry/Biospecimen Collection
Other interventionblood, urine, CFS samples and medical data collected
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: Database Entry / Biospecimen Collection1 intervention
Trial outcomes
Primary outcomes
1
Number of Blood Samples
Blood samples-based data of genetic and biomarkers for the monitoring of neonatal encephalopathy.
Time frame
In 72 hours2
Number of Urine Samples
Urine samples-based data of biomarkers for the monitoring of neonatal encephalopathy.
Time frame
In 72 hoursSecondary outcomes
1
Number of Electronic Medical Records
To collect systemic medical information about neonatal encephalopathy.
Time frame
To follow for the duration of hospital stay, an expected average of 4 weeks2
Neurodevelopment(Bayley Scores)
To evaluate neurodevelopmental function via Bayley Scores of Infant Development Mental Development Index (BSIDMI) and gain incidence of BSIMDI\<70(Severe) or BSIMDI\<85(Moderate).
Time frame
At the age of 18 months3
Neurological Evaluation(GMFM-88 Scores)
To gain changes in standardized gross motor function using GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales, lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping (range: 0\~100 , Higher value means better gross motor function).
Time frame
At the age of 18 months4
Gene Mutation
To detect the mutation and characterize the genetic architecture and risk variants of neonatal malformation using different genomic methods.
Time frame
At the age of 28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Fudan University
Lead sponsor
Xiamen Children's Hospital, Fujian of China
Collaborator
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Collaborator
Guangzhou Women and Children's Medical Center
Collaborator
Yuying Children's Hospital of Wenzhou Medical University
Collaborator
Maternal and Child Health Hospital of Hubei Province
Collaborator
The People's Hospital of Dehong Autonomous Prefecture
Collaborator
Guangzhou Medical University
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Source ClinicalTrials.gov