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| Name | Class |
|---|---|
| Xiamen Children's Hospital, Fujian of China | OTHER |
| Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| Guangzhou Women and Children's Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Database Entry/Biospecimen Collection | Other | blood, urine, CFS samples and medical data collected |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Blood Samples | Blood samples-based data of genetic and biomarkers for the monitoring of neonatal encephalopathy. | In 72 hours |
| Number of Urine Samples | Urine samples-based data of biomarkers for the monitoring of neonatal encephalopathy. | In 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Electronic Medical Records | To collect systemic medical information about neonatal encephalopathy. | To follow for the duration of hospital stay, an expected average of 4 weeks |
| Neurodevelopment(Bayley Scores) |
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Inclusion Criteria:
Postnatal age < or = 28 days
Written informed consent of parent or guardian
With one of the following items
Hypoxic ischemic encephalopathy (HIE)
Hydrocephalus
Hypotonia
Interventricular hemorrhages
Intracranial calcifications
Intracranial hemorrhages
Meningitis and other brain infections
Metabolic diseases
Microcephaly
Neonatal stroke
Spina bifid
Cerebral arteriovenous malformations (AVMs)
Congenital brain malformations
Exclusion Criteria:
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Neonatal with severe encephalopathy or suspected severe encephalopathy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenhao Zhou, Doctor | Contact | zwhchfu@126.com | ||
| Guoqiang Cheng, Doctor | Contact | gqchengcm@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenhao Zhou, Doctor | Children's Hospital of Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 201102 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21792751 | Background | 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. | |
| 17558117 | Background | Narayanan JT, Murthy JM. New-onset acute symptomatic seizure in a neurological intensive care unit. Neurol India. 2007 Apr-Jun;55(2):136-40. doi: 10.4103/0028-3886.32784. |
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| Yuying Children's Hospital of Wenzhou Medical University | OTHER |
| Maternal and Child Health Hospital of Hubei Province | OTHER |
| The People's Hospital of Dehong Autonomous Prefecture | OTHER |
| Guangzhou Medical University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
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Blood, Urine and CSF samples
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).
| At the age of 18 months |
| 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). | At the age of 18 months |
| Gene Mutation | To detect the mutation and characterize the genetic architecture and risk variants of neonatal malformation using different genomic methods. | At the age of 28 days |
| 21792753 | Background | 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. |
| 25727504 | Background | 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. No abstract available. |
| 25727512 | Background | 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. |
| 25727506 | Background | 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. |
| 25693892 | Background | 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. |
| 23419471 | Background | 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. |
| 21808297 | Background | 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. |
| 30180407 | Derived | Liu L, Xu SH, Zhang P, Lu CM, Cheng GQ. [Effect of red blood cell transfusion on the oxygenation of mesenteric tissue in premature infants]. Zhonghua Er Ke Za Zhi. 2018 Sep 2;56(9):680-685. doi: 10.3760/cma.j.issn.0578-1310.2018.09.009. Chinese. |