Objective Neurocognitive Assessment of Young Children With Sickle Cell Disease by Eye-Tracking (ONSET)
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Amsterdam、オランダ、1105AZ
- Amsterdam UMC
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age 6 - 24 months old
- Inhabitant of the Netherlands
- Written informed consent from parent/caretaker.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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Patient group
Infants between 6 and 24 months of age diagnosed with sickle cell disease
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Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.
proteomics analyses methylation analyses
The strengths and difficulties questionnaire is a conventional instrument used to measure the presence of psychosocial problems, the child's strengths and the influence of psychosocial problems on daily functioning.
The TNO-AZL Preschool Children Quality of Life is a questionnaire that measures the health-related quality of life of children over the last three months
The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants
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Healthy subject group
Infants between 6 and 24 months of age without sickle cell disease
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Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.
The strengths and difficulties questionnaire is a conventional instrument used to measure the presence of psychosocial problems, the child's strengths and the influence of psychosocial problems on daily functioning.
The TNO-AZL Preschool Children Quality of Life is a questionnaire that measures the health-related quality of life of children over the last three months
The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Processing speed in the gap condition (Gap/Overlap task)
時間枠：T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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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)
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T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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Processing accuracy in the gap condition (Gap/Overlap task)
時間枠：T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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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 |
T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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Orienting attention speed in the overlap condition (Gap/Overlap task)
時間枠：T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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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 (%) |
T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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Orienting attention accuracy in the overlap condition (Gap/Overlap task)
時間枠：T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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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 |
T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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Alerting attention without external cues (Gap/Overlap task)
時間枠：T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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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 |
T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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Sustained attention across trials (Gap/Overlap task)
時間枠：T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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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 (%) |
T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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Fixation duration during free viewing (Freeview task)
時間枠：T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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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) |
T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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Habituation (Habituation task)
時間枠：T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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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 |
T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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Recognition (Habituation task)
時間枠：T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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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 (%) |
T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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Novelty preference (Habituation task)
時間枠：T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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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 (%) |
T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Demographic and perinatal characteristics assessed via parent-reported questionnaire
時間枠：At study visit of 6, 12 18 or 24 months of age, depending on the enrollment age. The first visit in the study
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Demographic and perinatal information collected via a structured parent/caretaker questionnaire, including child age, sex, ethnicity, country of origin, parental education level (as proxy for socioeconomic status), and perinatal information (e.g. breastfeeding, birth characteristics). Clinical characteristics (e.g. SCD genotype, disease severity, treatment) are extracted from electronic health records. Unit of Measure: Categorical and continuous variables (reported descriptively) |
At study visit of 6, 12 18 or 24 months of age, depending on the enrollment age. The first visit in the study
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Behavioral and emotional functioning assessed using the Strengths and Difficulties Questionnaire (SDQ)
時間枠：study visit at 24 months of age
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Parent-reported behavioral and emotional functioning measured using the SDQ, a validated screening instrument. The SDQ assesses five domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Scores are reported per subscale and as a total difficulties score. Unit of Measure: Scale score (0-40 total difficulties score) |
study visit at 24 months of age
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Development assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)
時間枠：study visit at 24 months of age
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Standardized assessment of development administered by a trained examiner at age 24 months using the BSID-III (Cognitive and Motor Scale).
Scores are reported as scaled scores with a normative mean of 10 (SD=3).
Unit of Measure: Scaled score
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study visit at 24 months of age
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Plasma proteomic biomarker profile assessed via blood sample in children with SCD
時間枠：study visit at 12 months of age and study visit at 24 months of age
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A blood sample is collected from children with SCD to identify plasma proteomic biomarkers related to disease severity and neurological functioning. Samples are analyzed using unbiased proteomics analyses to characterize protein expression profiles. Unit of Measure: Protein expression levels (reported as relative abundance) |
study visit at 12 months of age and study visit at 24 months of age
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NL82004.018.22
- 2022.0539 (その他の識別子：Amsterdam UMC)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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