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Recruiting NCT02544100

Neonatal Neurologic Intensive Care Network of China

— Observational Neonatal Encephalopathy Suspected Neonatal Encephalopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Database Entry/Biospecimen Collection.
Who it may be relevant to
Registry conditions: Neonatal Encephalopathy, Suspected Neonatal Encephalopathy. Basic parameters: up to 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Number of Blood Samples [Time frame: In 72 hours]
  • Number of Urine Samples [Time frame: In 72 hours]
Secondary outcome measures (4)
  • Number of Electronic Medical Records [Time frame: 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]
  • Neurological Evaluation(GMFM-88 Scores) [Time frame: At the age of 18 months]
  • Gene Mutation [Time frame: At the age of 28 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Children Hospital of Fudan University — Shanghai

Publications

  • 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 21792751
  • 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 17558117
  • 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 21792753
  • 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 25727504
  • 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 25727512
  • 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 25727506
  • 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 25693892
  • 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 23419471

Identifiers

NCT: NCT02544100 · CHFudanU_NNICU5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗