Objective Neurocognitive Assessment of Young Children With Sickle Cell Disease by Eye-Tracking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Processing speed in the gap condition (Gap/Overlap task)
研究概览
简要总结
Evidence indicates that Sickle Cell Disease (SCD) threatens neurodevelopmental outcome. Although children with SCD may be heterogeneously affected, neurocognitive impairment may already be present in toddlers. Neurocognitive functioning is an important determinant of adaptive daily life functioning later in life and is influenced by both the course of the disease and the often suboptimal environment in which afflicted children grow up. Early identification of children at the highest risk of neurocognitive impairment would enable the deployment of early interventions to mitigate the detrimental effects of SCD on the developing brain. In order to develop such interventions, a deeper understanding of the underlying pathophysiological mechanisms is required. Therefore the main aim is to study early neurocognitive functioning and development in children with SCD between the ages of 6 and 24 months old.
详细描述
Objective
The main aim is to study early neurocognitive functioning and development in very young children with SCD. The secondary aims are to 1) (i) identify demographic, psychosocial and clinical determinants and (ii) identify biomarkers associated with early neurocognitive deficits in young children with SCD. 2) Analyze the association between early neurocognitive functioning and adaptive daily life functioning.
Study design: Prospective observational study with an accelerated longitudinal design. The accelerated longitudinal design allows for the inclusion of children from a broad age range (6 - 24 months). During the total study period of 30 months, children can enroll in the study at the ages of 6, 12, 18 and 24 months. After enrollment, children will visit every 6 months until they reach the age of 24 months. This design spans the age range of interest in a shorter period of time and a smaller load on participants as compared to a conventional longitudinal design.
Methods: Eye-tracking measurements will take place at every study visit. Demographic, psychosocial and clinical characteristics of the SCD group will be collected using prospective and structured clinical registration as part of regular clinical care. Demographic, psychosocial and clinical information of the control group will be collected using a parent questionnaire administered during the first and last study visit. Blood samples of children with SCD will be taken as part of regular blood checks at the age of 12 and/or 24 months (depending on the age of enrollment in the study). The Child Behavior Checklist, TNO AZL Preschool Children Quality of Life and the Bayley Scale of Infant and Child Development will be administered to all children at the age of 24 months.
Main study parameters/endpoints: Neurocognitive functioning, as measured using eye-tracking.
Secondary study parameters/ endpoints: The following determinants will be measured: Demographic, psychosocial and clinical characteristics, as measured as part of regular clinical care (SCD group) or via parent questionnaire (control group) and Biomarkers, as measured in blood (SCD group). Adaptive daily life functioning, as measured by quality of life, behavioural and emotional functioning questionnaire, and general (cognitive) development 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
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6 - 24 months old
- •Inhabitant of the Netherlands
- •Written informed consent from parent/caretaker.
排除标准
- •Refused informed consent from parents/care-taker
- •Diagnosis of visual impairment (which cannot be corrected by glasses)
- •Diagnosis of a (co-morbid) congenital developmental condition
- •Any neurological condition, unrelated to SCD, that could affect the central nervous system, such as brain trauma, epilepsy and meningitis/encephalitis.
结局指标
主要结局
Processing speed in the gap condition (Gap/Overlap task)
时间窗: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The speed of responding to a novel peripheral stimulus when the central stimulus disappears before the peripheral target appears. Measured as reaction time (RT) via eye-tracking in infants with sickle cell disease (SCD). Unit of Measure: Milliseconds (ms)
Processing accuracy in the gap condition (Gap/Overlap task)
时间窗: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The precision of responding to a novel peripheral stimulus when the central stimulus disappears before the peripheral target appears. Measured as a binomial outcome (accurate/inaccurate) per trial via eye-tracking in infants with SCD. Unit of Measure: Proportion of accurate trials
Orienting attention speed in the overlap condition (Gap/Overlap task)
时间窗: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The speed of orienting attention away from a central stimulus toward a peripheral target when the central stimulus remains on screen. Measured as RT in the overlap condition expressed as percentage change relative to mean RT in the gap condition, via eye-tracking in infants with SCD. Unit of Measure: Percentage (%)
Orienting attention accuracy in the overlap condition (Gap/Overlap task)
时间窗: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The precision of orienting attention toward a peripheral target when the central stimulus remains on screen. Measured as a binomial outcome (accurate/inaccurate) per trial via eye-tracking in infants with SCD. Unit of Measure: Proportion of accurate trials
Alerting attention without external cues (Gap/Overlap task)
时间窗: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The ability to maintain focus on the task without external attention-grabbing cues. Measured as a binomial outcome per trial (completed without attention grabber: yes/no) via eye-tracking in infants with SCD. Unit of Measure: Proportion of trials completed without attention grabber
Sustained attention across trials (Gap/Overlap task)
时间窗: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The ability to attend to the task over a longer period. Measured as the number of trials completed expressed as a percentage of the total possible trials, via eye-tracking in infants with SCD. Unit of Measure: Percentage (%)
Fixation duration during free viewing (Freeview task)
时间窗: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The amount of time the eyes remain stably focused on a specific location, defined as periods of stable gaze between successive saccades. Measured as mean fixation duration via eye-tracking in infants with SCD. Unit of Measure: Milliseconds (ms)
Habituation (Habituation task)
时间窗: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The process of becoming accustomed to a repeatedly presented stimulus. Measured as the number of trials required to reach the pre-defined habituation criterion via eye-tracking in infants with SCD. Unit of Measure: Number of trials
Recognition (Habituation task)
时间窗: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The ability to distinguish a previously presented stimulus from a novel one. Measured as the absolute difference in looking time toward the habituation stimulus versus the novel stimulus, via eye-tracking in infants with SCD. Unit of Measure: Percentage (%)
Novelty preference (Habituation task)
时间窗: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The tendency to inspect a novel stimulus relative to a previously presented one. Measured as looking time toward the novel stimulus as a percentage of total looking time, via eye-tracking in infants with SCD. Unit of Measure: Percentage (%)
次要结局
- Demographic and perinatal characteristics assessed via parent-reported questionnaire(At study visit of 6, 12 18 or 24 months of age, depending on the enrollment age. The first visit in the study)
- Behavioral and emotional functioning assessed using the Strengths and Difficulties Questionnaire (SDQ)(study visit at 24 months of age)
- Development assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)(study visit at 24 months of age)
- Plasma proteomic biomarker profile assessed via blood sample in children with SCD(study visit at 12 months of age and study visit at 24 months of age)
研究者
Karin Fijnvandraat
prof. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)