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临床试验/NCT02042716
NCT02042716已完成不适用

Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Sequences quantitative elastography and ultra-sensitive Doppler ultrasound performed on AixplorerTM (V2) data of brain MRI preterm infants.

研究概览

简要总结

Preterm birth and perinatal events related can interrupt microscopic maturation of the developing white matter leading to diffuse injury and subsequent neurocognitive impairments. Brain maturation can be studied using diffusion tensor imaging but is difficult to assess early after birth, repeatedly and at the bedside. Supersonic Shear wave Imaging (SSI) could be of interest in this clinical setting. This technique, already investigated in adults (breast, thyroid or liver fibrosis staging), has not been yet evaluated in neonates.

Objective:

To describe the feasibility and reproducibility of quantitative elasticity mapping in preterm infants and to correlate to gestational age.

Methods:

SSI is a quantitative stiffness imaging technique based on the combination of a remote palpation induced into tissues by the radiation force a focused ultrasonic beam and an ultrafast ultrasound imaging sequence. Such ultrafast frame rates permit to track in real time the displacements induced by the propagation of the resulting shear waves. For each pixel, the shear wave speed can be estimated locally and enables quantitative mapping of the local shear elasticity (characterizing the stiffness in kPa). In this study, we will use a new generation of ultrafast ultrasound scanners (Aixplorer®, Supersonic Imagine, Aix en Provence, France) with a linear L10-2 probe (256 elements, 6 MHz) in neonates born between 25 and 40 weeks' gestation (n=100). Three separate acquisitions will be obtained for each area of interest both on right and left sides and stiffness was measured using a unique ROI of 2.5 cm².

详细描述

White matter damage occurs in 20% of preterm infants in industrialized countries. These lesions are difficult to evaluate by standard ultrasound. The quantitative elastography is a new medical imaging technique and potentially a diagnostic tool in brain lesions in preterm infants. Shear wave Imaging (SSI) could be of interest in this clinical setting. This technique, already investigated in adults (breast, thyroid or liver fibrosis staging), has not been yet evaluated in neonates.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
24 Weeks 至 40 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • gestational age between 24 +0 and 31 +6 j GA) and 39 +0 and 40 +6 d (control group)
  • Inborn or Outborn
  • Informed consent of the holders of the exercise of parental authority
  • recipient of a social security system (excluding AME) Child

排除标准

  • Malformation known pathology;
  • Known chromosomal abnormality;

结局指标

主要结局

Sequences quantitative elastography and ultra-sensitive Doppler ultrasound performed on AixplorerTM (V2) data of brain MRI preterm infants.

时间窗: Up to on 40GA + /-1week fo preterm infants<32GA. For newborns at term:on day3+-1d

To describe the feasibility and reproducibility of quantitative elasticity mapping in preterm infants and to correlate to gestational age * For preterm infants \<32GA: Quantitative elasticity mapping will be repeated at different stages of postnatal development of preterm infants: on day0-day1, day3 + /-1d, day8, day21 + /-1d; 40GA + /-1week. * For newborns at term (39-40GA +6 d) : Quantitative elasticity mapping will be performed on day3+-1

次要结局

  • Quantitative cerebral perfusion values obtained by Doppler ultra-sensitive(up to 40GA + /-1week for preterm infants <32GA .For newborns at term :on day3+-1)
  • Cerebral perfusion values obtained by Doppler ultra-sensitive(on day21 + /-1d)
  • Correlation and comparison of measures elastography MRI to determine the prognosis of brain abnormalities detected by elastography(For preterm infants <32GA:up to 40GA+/-1 week.For newborns at term :on day3+-1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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