Neonatal Neurologic Intensive Care Network of China
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Database Entry/Biospecimen Collection.
- Кому может быть актуально
- Состояния в реестре: Neonatal Encephalopathy, Suspected Neonatal Encephalopathy. Базовые параметры: до 28 Days · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Database Entry/Biospecimen Collection
blood, urine, CFS samples and medical data collected
Первичные конечные точки
- Number of Blood Samples [Срок оценки: In 72 hours]
- Number of Urine Samples [Срок оценки: In 72 hours]
Вторичные конечные точки (4)
- Number of Electronic Medical Records [Срок оценки: To follow for the duration of hospital stay, an expected average of 4 weeks]
- Neurodevelopment(Bayley Scores) [Срок оценки: At the age of 18 months]
- Neurological Evaluation(GMFM-88 Scores) [Срок оценки: At the age of 18 months]
- Gene Mutation [Срок оценки: At the age of 28 days]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Китай · 1 центр
- Children Hospital of Fudan University — Шанхай
Публикации
- 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
Идентификаторы
NCT: NCT02544100 · CHFudanU_NNICU5