Neonatal Neurologic Intensive Care Network of China
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 mainly including demographic, medical history, family condition, perinatal stage information, birth, growth & feeding status, imaging, 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. There are seven children's hospitals from 6 provinces in China to join in the collaboration network in first recruiting. In addition, the following biological samples will be collected in a bio-bank for future studies: blood, urine, and cerebrospinal fluid (CSF) samples.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Database Entry / Biospecimen Collection Systematic Medical information of infants born with severe encephalopathy entered into database. In addition, Blood, urine, CFS samples will be collected. |
Other: Database Entry/Biospecimen Collection
blood, urine, CFS samples and medical data collected
|
Outcome Measures
Primary Outcome Measures
- Number of Blood Samples [In 72 hours]
Blood samples-based data of genetic and biomarkers for the monitoring of neonatal encephalopathy.
- Number of Urine Samples [In 72 hours]
Urine samples-based data of biomarkers for the monitoring of neonatal encephalopathy.
Secondary Outcome Measures
- Number of Electronic Medical Records [To follow for the duration of hospital stay, an expected average of 4 weeks]
To collect systemic medical information about neonatal encephalopathy.
- Neurodevelopment(Bayley Scores) [At the age of 18 months]
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).
- Neurological Evaluation(GMFM-88 Scores) [At the age of 18 months]
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).
- Gene Mutation [At the age of 28 days]
To detect the mutation and characterize the genetic architecture and risk variants of neonatal malformation using different genomic methods.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Postnatal age < or = 28 days
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Written informed consent of parent or guardian
With one of the following items
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Hypoxic ischemic encephalopathy (HIE)
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Hydrocephalus
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Hypotonia
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Interventricular hemorrhages
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Intracranial calcifications
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Intracranial hemorrhages
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Meningitis and other brain infections
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Metabolic diseases
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Microcephaly
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Neonatal stroke
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Spina bifid
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Cerebral arteriovenous malformations (AVMs)
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Congenital brain malformations
Exclusion Criteria:
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Known other major congenital anomalies but not not neurologic disease.
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Failed to get sample or the volume of collected biosamples is not enough.
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Parents refuse consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children Hospital of Fudan University | Shanghai | Shanghai | China | 201102 |
Sponsors and Collaborators
- Children's Hospital of Fudan University
- Xiamen Children's Hospital, Fujian of China
- Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
- Guangzhou Women and Children's Medical Center
- Yuying Children's Hospital of Wenzhou Medical University, Zhejiang of China
- Maternal and Child Health Hospital of Hubei Province
- The People's Hospital of Dehong Autonomous Prefecture
- Guangzhou Medical University
- Nanfang Hospital of Southern Medical University
Investigators
- Study Chair: Wenhao Zhou, Doctor, Children's Hospital of Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
- Bonifacio SL, Glass HC, Peloquin S, Ferriero DM. A new neurological focus in neonatal intensive care. Nat Rev Neurol. 2011 Aug 2;7(9):485-94. doi: 10.1038/nrneurol.2011.119. Review.
- Hall CE, Mirski M, Palesch YY, Diringer MN, Qureshi AI, Robertson CS, Geocadin R, Wijman CA, Le Roux PD, Suarez JI; First Neurocritical Care Research Conference Investigators. Clinical trial design in the neurocritical care unit. Neurocrit Care. 2012 Feb;16(1):6-19. doi: 10.1007/s12028-011-9608-6. Review.
- LaRovere KL, Graham RJ, Tasker RC; Pediatric Critical Nervous System Program (pCNSp). Pediatric neurocritical care: a neurology consultation model and implication for education and training. Pediatr Neurol. 2013 Mar;48(3):206-11. doi: 10.1016/j.pediatrneurol.2012.12.006.
- Murphy SA, Bell MJ, Clark ME, Whalen MJ, Noviski N. Pediatric Neurocritical Care: A Short Survey of Current Perceptions and Practices. Neurocrit Care. 2015 Oct;23(2):149-58. doi: 10.1007/s12028-015-0120-2.
- Narayanan JT, Murthy JM. New-onset acute symptomatic seizure in a neurological intensive care unit. Neurol India. 2007 Apr-Jun;55(2):136-40.
- Riviello JJ Jr, Chang C. The practice of pediatric neurocritical care by the child neurologist. Semin Pediatr Neurol. 2014 Dec;21(4):299-302. doi: 10.1016/j.spen.2014.12.007. Epub 2014 Dec 13. Review.
- Riviello JJ Jr. Pediatric neurocritical care. Introduction. Semin Pediatr Neurol. 2014 Dec;21(4):239-40. doi: 10.1016/j.spen.2014.12.009. Epub 2014 Dec 19.
- Suarez JI, Geocadin R, Hall C, Le Roux PD, Smirnakis S, Wijman CA, Zaidat OO. The neurocritical care research network: NCRN. Neurocrit Care. 2012 Feb;16(1):29-34. doi: 10.1007/s12028-011-9612-x. Review.
- Wainwright MS, Grimason M, Goldstein J, Smith CM, Amlie-Lefond C, Revivo G, Noah ZL, Harris ZL, Epstein LG. Building a pediatric neurocritical care program: a multidisciplinary approach to clinical practice and education from the intensive care unit to the outpatient clinic. Semin Pediatr Neurol. 2014 Dec;21(4):248-54. doi: 10.1016/j.spen.2014.10.006. Epub 2014 Nov 1.
- CHFudanU_NNICU5
- NCT02606656