Neonatal Neurologic Intensive Care Network of China

September 3, 2025 updated by: Children's Hospital of Fudan University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201102
        • Recruiting
        • Children Hospital of Fudan University
        • Contact:
          • Wenhao Zhou, Doctor
          • Phone Number: (+86)021-64931003
          • Email: zwhchfu@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Neonatal with severe encephalopathy or suspected severe encephalopathy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Blood Samples
Time Frame: In 72 hours
Blood samples-based data of genetic and biomarkers for the monitoring of neonatal encephalopathy.
In 72 hours
Number of Urine Samples
Time Frame: In 72 hours
Urine samples-based data of biomarkers for the monitoring of neonatal encephalopathy.
In 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Electronic Medical Records
Time Frame: To follow for the duration of hospital stay, an expected average of 4 weeks
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)
Time Frame: 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).
At the age of 18 months
Neurological Evaluation(GMFM-88 Scores)
Time Frame: 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).
At the age of 18 months
Gene Mutation
Time Frame: 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.
At the age of 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Collaborators

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

Investigators

  • Study Chair: Wenhao Zhou, Doctor, Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimated)

September 9, 2015

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHFudanU_NNICU5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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