Neonatal Neurologic Intensive Care Network of China

Neonatal Encephalopathy Clinical Trial

Official title:

Neonatal Neurologic Intensive Care Network of China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02544100
• Other study ID #: CHFudanU_NNICU5
• Status: Recruiting
• Start date: September 1, 2015
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: Children's Hospital of Fudan University
• Contact: Wenhao Zhou, Doctor
• Email: zwhchfu[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02606656

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

1. Postnatal age < or = 28 days

2. Written informed consent of parent or guardian

With one of the following items

3. Hypoxic ischemic encephalopathy (HIE)

4. Hydrocephalus

5. Hypotonia

6. Interventricular hemorrhages

7. Intracranial calcifications

8. Intracranial hemorrhages

9. Meningitis and other brain infections

10. Metabolic diseases

11. Microcephaly

12. Neonatal stroke

13. Spina bifid

14. Cerebral arteriovenous malformations (AVMs)

15. Congenital brain malformations

Exclusion Criteria:

1. Known other major congenital anomalies but not not neurologic disease.

2. Failed to get sample or the volume of collected biosamples is not enough.

3. Parents refuse consent.

Related Conditions & MeSH terms

• Brain Diseases
• Neonatal Encephalopathy
• Suspected Neonatal Encephalopathy

Intervention

Other:
• Database Entry/Biospecimen Collection
blood, urine, CFS samples and medical data collected

Locations

Country	Name	City	State
China	Children Hospital of Fudan University	Shanghai	Shanghai

Sponsors (9)

Lead Sponsor

Collaborator

Children's Hospital of Fudan University

Guangzhou Medical University, Guangzhou Women and Children's Medical Center, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Maternal and Child Health Hospital of Hubei Province, Nanfang Hospital, Southern Medical University, The People's Hospital of Dehong Autonomous Prefecture, Xiamen Children's Hospital, Fujian of China, Yuying Children's Hospital of Wenzhou Medical University, Zhejiang of China

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Blood Samples	Blood samples-based data of genetic and biomarkers for the monitoring of neonatal encephalopathy.	In 72 hours
Primary	Number of Urine Samples	Urine samples-based data of biomarkers for the monitoring of neonatal encephalopathy.	In 72 hours
Secondary	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
Secondary	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).	At the age of 18 months
Secondary	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
Secondary	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