NCT02544100

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

10.3 years

First QC Date

September 4, 2015

Last Update Submit

September 3, 2025

Conditions

Neonatal EncephalopathySuspected Neonatal Encephalopathy

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • Number of Electronic Medical Records

    To follow for the duration of hospital stay, an expected average of 4 weeks

  • Neurodevelopment(Bayley Scores)

    At the age of 18 months

  • Neurological Evaluation(GMFM-88 Scores)

    At the age of 18 months

  • Gene Mutation

    At the age of 28 days

Study Arms (1)

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

Interventions

Database Entry/Biospecimen CollectionOTHER

blood, urine, CFS samples and medical data collected

Database Entry / Biospecimen Collection

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonatal with severe encephalopathy or suspected severe encephalopathy.

You may qualify if:

  • 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)
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Related Publications (10)

  • 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.

    PMID: 21792751BACKGROUND

  • 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.

    PMID: 17558117BACKGROUND

  • 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.

    PMID: 21792753BACKGROUND

  • 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.

    PMID: 25727504BACKGROUND

  • 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.

    PMID: 25727512BACKGROUND

  • 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.

    PMID: 25727506BACKGROUND

  • 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.

    PMID: 25693892BACKGROUND

  • 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.

    PMID: 23419471BACKGROUND

  • 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.

    PMID: 21808297BACKGROUND

  • 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.

    PMID: 30180407DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine and CSF samples

Study Officials

  • Wenhao Zhou, Doctor

    Children's Hospital of Fudan University

    STUDY CHAIR

Central Study Contacts

Wenhao Zhou, Doctor

CONTACT

zwhchfu@126.com

Guoqiang Cheng, Doctor

CONTACT

gqchengcm@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 9, 2015

Study Start

September 1, 2015

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

September 5, 2025

Record last verified: 2025-09

Locations

CN(1)