CONEXUS: Prospective Study of the Feasibility of Brain Connectivity Imaging by Functional Ultrasound Imaging (fUS) in Newborn Infant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Feasibility of acquiring quantitative brain functional connectivity assessment using fUS data in 4 groups (G1 to G4) of newborns at high risk of neurodevelopmental disorder and a control group of term newborns.
研究概览
简要总结
Neurodevelopmental disorders (NDD) affect how the brain develops and can lead to lifelong difficulties with movement, learning, behavior, and thinking. Every year, around one million newborns in Europe are affected by these conditions. Some babies are at higher risk of NDD due to factors such as being born extremely premature, having poor growth in the womb, experiencing a lack of oxygen at birth, or having a family history of severe NDD. However, predicting which babies will develop these disorders is currently very challenging because there are no reliable early indicators (biomarkers) to detect them.
The CONEXUS study is testing a new type of brain imaging technology called functional ultrasound imaging (fUS) to see if it can help assess brain function in newborns at high risk of NDD. This technique measures brain activity by detecting small changes in blood flow, similar to an ultrasound scan but using advanced imaging technology. Researchers believe this method, known as fC-fUS imaging, could help identify early signs of neurodevelopmental disorders.
Preliminary studies have shown that fUS imaging can detect brain activity changes in newborns, such as differences between sleep states or during epileptic seizures. The CONEXUS study will expand on this by improving the imaging technology and testing it in a larger group of newborns, including those born prematurely, those with restricted growth, those who needed cooling treatment after birth due to lack of oxygen, and those at risk for autism spectrum disorder (ASD).
The study is being conducted in multiple hospitals in France over five years, involving newborn intensive care, pediatrics, and child psychiatry teams. It is a feasibility study, meaning researchers aim to test whether this imaging technique is practical and effective for use in newborns. Babies will have short, painless fUS scans that focus on brain regions involved in movement, hearing, vision, and attention.
Ultimately, the goal of CONEXUS is to demonstrate that fC-fUS imaging can help doctors understand early brain development and identify signs of neurodevelopmental disorders before symptoms appear. If successful, this technique could improve early diagnosis, allowing doctors to start treatment sooner and improve long-term outcomes for affected children. This research has the potential to transform neonatal care by providing a new tool for detecting and monitoring brain function in newborns.
详细描述
Introduction
Neurodevelopmental disorders (NDD) result from an alteration in brain development and represent a major public health problem, affecting 1 million newborns in Europe each year. Neurodevelopmental disorders are the source of permanent disabilities that manifest as motor, cognitive, learning, or behavioral dysfunction. Prenatal or neonatal factors considered high risk for NDD include: extreme prematurity, newborns with intrauterine growth retardation, brain growth abnormalities, anoxic-ischemic encephalopathy (AIE) with an indication for therapeutic hypothermia, and a family history of severe NDD in the first degree. Establishing a reliable prognosis for neurodevelopmental disorders is extremely difficult because there are currently no early biomarkers to detect and assess potential long-term deficiencies.
The CONEXUS protocol aims to evaluate whether a unique neuroimager, using ultrafast ultrasound imaging, is capable of assessing, at the patient's bedside, the brain's functional connectivity (fC) in newborns at high risk of NDD. This neuroimager uses functional ultrasound imaging (fUS), a technique developed within the Physics for Medicine laboratory (Paris), and thus constitutes the central medical device of this protocol.
Device
The CONEXUS system is composed of several elements necessary for functional brain imaging of newborns: the Conexus station (similar to an ultrasound machine) on which the Conexus software is installed (allowing the acquisition and processing of ultrasound data necessary for imaging), the ultrasound probe (a physical element allowing the emission and reception of ultrasounds, similar to an ultrasound probe), and the headset (a small system adapted to the anatomy of the patient's head and allowing the probe to be held in place over the fontanelle).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- — 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. For group G1 (Premature babies):
- •Gestational children:
- •1a. Between 23 WA+5 days and 27 WA +6 days (extremely preterm) (G1) or
- •1b. Between 28 WA+0 days and 31 WA+6 days (very preterm) (G1)
- •2. For the G2 group (AIE):
- •Children of gestational age> 36 WA + 0 days
- •with neonatal anoxo-ischemic encephalopathy
- •treated with controlled therapeutic hypothermia (group G2)
- •3. For the G3 Group (IUGR): Gestational age between 32 WA+0 days and 40 WA+6 days and with IUGR intrauterine growth restriction: birth weight < 10 p and/or head circumference < 10 percentile (G3 group);
- •4. For the G4 group :
- •Siblings with at least one child with signs of autism spectrum disorder
- •less than 6 months of age at baseline (G4 group)
- •5. For the G5 group (control):
- •Children of gestational age between 39 WA and 40 WA + 6 days
- •without pathology during pregnancy (no vasculoplacental pathology, no threat of premature delivery, no maternal corticosteroid therapy, no consumption of toxic substances)
- •at birth: Apgar greater than 6 at M10; pH>7.20; lactate< 6 mmol/l; eutrophic; Birth weight >10p; Cranial Perimeter >10p
- •6. Consent of the holders of parental authority
- •Child affiliated to or in receipt of a social security scheme
排除标准
- •Person subject to a judicial safeguard measure (guardianship, curatorship or safeguard of justice)
- •Known malformative pathology;
- •Known chromosomal abnormality;
- •Known allergy to silicone
研究组 & 干预措施
Feasibility of brain connectivity imaging by functional ultrasound imaging (fUS) in newborn infant
干预措施: Imaging Time (Device)
结局指标
主要结局
Feasibility of acquiring quantitative brain functional connectivity assessment using fUS data in 4 groups (G1 to G4) of newborns at high risk of neurodevelopmental disorder and a control group of term newborns.
时间窗: up to 16 weeks
Each fUS acquisition, for each patient, each acquisition time point, each imaging plane, consists of a succession of fUS images recorded over a duration ranging from 5 to 10 minutes. The acquisition will be considered successful if at least 50% of the fUS images do not show motion artifacts (criterion used in our preliminary studies) (validity criterion) and if vascular structures are visible at a depth \>50% of the maximum depth (sensitivity criterion). If these two criteria are met, we can then average the fUS signal over the functional areas and calculate a correlation matrix.
次要结局
- Feasibility of longitudinal quantification of fUS connectivity of preterm (from birth to equivalent term age) and term newborns in different connectivity networks(up to 16 weeks)
- Potential correlation between fUS connectivity assessment and neuropsychological assessment at 2 years within the groups of newborns at high risk of neurodevelopmental disorder(2 years)
- Feasibility of acquisition of 3D vascular atlases specific to fUS imaging in order to document the evolution of cerebrovascular structures in newborns at high risk of neurodevelopmental disorder and term newborns(up to 16 weeks)
- Quantify potential correlates between fUS and EEG data thanks to the simultaneous fUS-EEG clinical recordings in newborns at high risk of neurodevelopmental disorder and term newborns.(up to 16 weeks)