Neonatal Neurologic Intensive Care Network of China

Recruiting

• Conditions: Neonatal Encephalopathy; Suspected Neonatal Encephalopathy
• Interventions: Other: Database Entry/Biospecimen Collection

• Registration Number: NCT02544100
• Lead Sponsor: Children's Hospital of Fudan University

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.

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 Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Database Entry / Biospecimen Collection	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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).

Trial Locations

Locations (1)

Children Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China