Quantitative 3D UltraSound Brain Imaging: Development of New Bedside Biomarkers to Better Predict Neurodevelopmental Outcomes in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Identifying new early imaging biomarkers to predict NDDs at 2 years of age.
研究概览
简要总结
Prematurity is a leading cause of neurodevelopmental disorders (NDDs) tightly associated with white matter damage, including punctate white matter lesions (PWMLs). Hence, an improved detection of brain injury early in life in infants born very preterm is a top priority to predict NDDs and therefore to assess potential neuroprotective strategies and implement early interventions. 3D and quantitative tools at the bedside using ultrasound are expected to better detect and quantify not only PWMLs but also other brain structures with promising prognostic value to predict NDDs at 2 years of age.
详细描述
Rationale :
Prematurity is a leading cause of neurodevelopmental disorders (NDDs). In Europe, 10% of the 50 000 children born very preterm will develop cerebral palsy and 35% will experience persistent cognitive and neuropsychiatric disorders, including autism, requiring long-term health care support. NDDs following preterm birth are tightly associated with white matter damage, including punctate white matter lesions (PWMLs), a promising marker of subsequent NDDs affecting up to 24% of very preterm infants. Hence, an improved detection of brain injury early in life in infants born very preterm is a top priority to predict NDDs and therefore to assess potential neuroprotective strategies and implement early interventions. Magnetic Resonance Imaging (MRI) is the gold standard to assess white matter integrity and has revealed an association between thalamus structure, ventricular dilatation, white matter damage, and NDDs at preschool age in infants born very preterm. However, it suffers from limited accessibility, low portability, and high sensitivity to motion artifacts mitigating its value for screening in all preterm infants at risk of NDDs. Conversely, conventional 2D cranial ultrasonography (cUS) is a tool widely used in neonatal intensive care units to prospectively screen brain lesions through the anterior fontanel. However, while suitable to detect severe lesions observed in 4-5% of very premature infants only, it remains less reliable for the comprehensive detection of PWMLs despite recent improvements. Hence, 3D and quantitative tools at the bedside using ultrasound must be developed to automatically detect and quantify not only PWMLs but also other brain structures with promising prognostic value.
Main objective:
Identifying new early imaging biomarkers to predict NDDs at 2 years of age.
Primary endpoint:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 23 Weeks 至 35 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Very preterm infants delivered (either inborn or outborn) between 23+0 and 29+6 weeks of gestation
- •Informed written consent of the holders of parental authority.
排除标准
- •Admission for palliative care
- •Chromosomal aberrations and major malformations evidenced after birth Major malformations
- •Chromosomal aberrations
- •No social security coverage
结局指标
主要结局
Identifying new early imaging biomarkers to predict NDDs at 2 years of age.
时间窗: 2 years
Correlation between 3D quantification of PWMLs burden, and results of Bayley Scale assessment, at 2 years of age and the Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire, which identifies preterm children at risk for developmental delays at 24 months of age.
次要结局
- Developing a processing pipeline allowing the reconstruction of 3D cUS volume & automatic detection and segmentation algorithms based on deep learning methods.(Between day 3±1 and day 21±3)
- Validating these models to detect PWMLs, & segment thalami and cerebral ventricular system (CVS).(2 years)
- Correlating thalami and CVS 3D longitudinal volumes in very preterm infants with & without PWMLs(2 years)