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NCT Number: NCT02544100

Neonatal Neurologic Intensive Care Network of China

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.

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Key information

Conditions

Neonatal Encephalopathy Suspected Neonatal Encephalopathy

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location status: Recruiting

Location contact

Wenhao Zhou, Doctor

CONTACT

[email protected]

(+86)021-64931003

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Known other major congenital anomalies but not not neurologic disease.
  • Failed to get sample or the volume of collected biosamples is not enough.
  • Parents refuse consent.

Treatment and study plan

Database Entry/Biospecimen Collection

Other

blood, urine, CFS samples and medical data collected

Primary outcomes

  1. Number of Blood Samples

    Time frame: In 72 hours

    Blood samples-based data of genetic and biomarkers for the monitoring of neonatal encephalopathy.

  2. Number of Urine Samples

    Time frame: In 72 hours

    Urine samples-based data of biomarkers for the monitoring of neonatal encephalopathy.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guoqiang Cheng, Doctor

CONTACT

[email protected]

Wenhao Zhou, Doctor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2015
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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