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临床试验/NCT02082535
NCT02082535Unknown不适用

S100B as a Marker of Brain Injury of Preterm Infants

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
MRI at term age

研究概览

简要总结

The improvement of treatment of preterm neonates improved their survival, however there is still significant portion of preterm infants (specifically very preterm infants) that suffers from brain insults and as a result developmental deficits. The brain injury is a consequence of hypoxic ischemic events, intracranial hemorrhages, as well as, infections and metabolic crisis. The brain injury is a combination of abnormal myelination, axonal damage and neuronal death. Although there is reduction in focal brain injury, diffuse brain injury is still abundant. Several treatments has been suggested and tested in animal models to prevent the brain insults including glutamate receptor blockers, allopurinol, xenon and different types of stem cells. However, two main obstacles prevent the use of these medication, first the uncertainty of their effect on the developing brain and second the difficulty to time the brain insult. Unlike neonatal asphyxia, when the delivery time and clinical signs are used to time and grade the brain injury, in preterm infants there is no real time tool to indicate severity and timing of brain injury. The disability point out a beneficial therapeutic window is a major obstacle in the acute treatment of brain injury in preterm infants. The aim of this study is to try and delineate such therapeutic window by using brain injury biomarkers.

S100b and GFAP are well recognized biomarkers of brain injury in adults, children and infants. Serial measurements of S100b in saliva (every 2 days) and GFAP in serum (weekly) will be sampled. A database of the clinical status of the infants will be collected, as well as, head ultra sound weekly and head MRI a term age. Development will be assessed by at 18 months. Two hypotheses are stated: One, increase in the levels of S100b and GFAP in their timing will be correlated with the severity of the clinical status, Two the duration of increased level of S100b and GFAP will be associated with abnormal MRI at term findings and abnormal developmental assessment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 2 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm delivery before 30 week gestational age

排除标准

  • Dysmorphic features in initial neurological examination
  • Antenatal brain injury on fetal MRI or ultrasound
  • Brain malformation
  • Maternal drug abuse
  • Maternal use of teratogenic medications

结局指标

主要结局

MRI at term age

时间窗: 2-3 month after recruitment

MRI description according to the protocol suggested by woodward et. al. (2006)

S100b and GFAP

时间窗: 2-3 months after recruitment

The level of S100b in a sample of 0.5 cc saliva will collected every 2 days and GFAP every week from the day of birth to discharge

次要结局

  • Developmental assessment at 18 month(21 month after recruitment)
  • Developmental assessment at 3 month corrected age(5-6 months after recuitment)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Omer Bar-Yosef

Physician

Sheba Medical Center

研究点 (1)

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