Predicting the Outcome of ADHD in White Matter Injure Neonates With Multi-modality MRI
Multi-center Longitudinal Clinical Study on the Evolution of Neonatal White Matter Injure to ADHD Based on Multi-modality MRI
The goal of this bidirectional observational cohort study is to investigate the longitudinal relationship between neonatal white matter injury (WMI) and the subsequent development of attention-deficit/hyperactivity disorder (ADHD), and to identify early MRI-based markers associated with ADHD-related outcomes. The study includes both retrospective and prospective cohorts to dynamically evaluate the evolution of brain injury, brain development, and behavioral outcomes from infancy to childhood.
The main questions it aims to answer are:
Are neonatal WMI characteristics associated with the subsequent development of ADHD? Which MRI-derived features, including semi-quantitative WMI assessment, microstructural alterations, and structural disconnection patterns, are associated with ADHD-related outcomes?
Participants with neonatal WMI will undergo longitudinal clinical, neurodevelopmental, and behavioral follow-up. Researchers will analyze clinical information and MRI findings to characterize WMI evolution and identify imaging markers associated with ADHD risk. Participants will:
undergo brain MRI examinations according to clinical protocols; receive standardized neurodevelopmental and behavioral assessments during follow-up; have MRI-derived measures, including semi-quantitative WMI scores, white matter microstructural features, and structural disconnection measures, analyzed to investigate their associations with ADHD-related outcomes.
調査の概要
詳細な説明
White matter injury (WMI) is a common form of neonatal brain injury and may be associated with altered brain development and later neurodevelopmental disorders. Previous studies have suggested that abnormalities in brain microstructure and connectivity after neonatal WMI may overlap with neural circuits involved in attention and executive function. However, the longitudinal evolution of neonatal WMI and its relationship with the development of attention-deficit/hyperactivity disorder (ADHD) remain incompletely understood.
This bidirectional observational cohort study will investigate the association between neonatal WMI characteristics and later ADHD-related outcomes through longitudinal clinical and neuroimaging follow-up. The study includes retrospective and prospective cohorts to characterize brain developmental trajectories after neonatal WMI.
Multimodal MRI analyses were performed to quantify WMI-related brain alterations, including conventional MRI-based semi-quantitative assessment, white matter microstructural measurements, and structural disconnection analysis. These MRI-derived features were evaluated in relation to subsequent neurodevelopmental and behavioral outcomes to identify early imaging markers associated with ADHD risk.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Hangzhou、中国
- Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
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Lanzhou、中国
- Gansu Province Maternity and Child Health Hospital
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Qinghai、中国
- Qinghai Red Cross Hospital
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Shijiazhuang、中国
- Hebei Children's Hospital
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Suzhou、中国
- Children's Hospital of Soochow University
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Wuxi、中国
- Wuxi Children's Hospital
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Xi'an、中国
- Northwest Women's and Children's Hospital
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Xianyang、中国
- The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
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Shaanxi
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Xi'an、Shaanxi、中国
- First Affiliated Hospital of Xi'an Jiaotong University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
The study population is derived from a multicenter neonatal and infant clinical and multimodal MRI database established through a national research project. The database includes clinical information and multimodal MRI data collected from multiple clinical centers. This bidirectional observational cohort study includes neonates with white matter injury (WMI) identified on brain MRI and control neonates without apparent abnormalities on routine MRI. Eligible participants will be screened from the existing database, and clinical characteristics, MRI findings, and longitudinal neurobehavioral outcomes will be analyzed to investigate the association between neonatal brain injury patterns and later developmental outcomes.
説明
Inclusion Criteria:
- Neonates diagnosed with white matter injury (WMI) or neonates without obvious abnormalities on routine MRI examination from the multicenter database.
- Brain MRI examination performed within 28 days after birth, with gestational age ≤42 weeks at examination.
- Complete MRI data available, including T1-weighted imaging (T1WI), T2-weighted imaging (T2WI), and diffusion tensor imaging (DTI).
- Complete maternal and pregnancy history information, neonatal demographic characteristics, and clinical information available.
Exclusion Criteria:
- Congenital nervous system developmental malformations or suspected genetic or metabolic diseases.
- Obvious MRI artifacts affecting image evaluation.
- Inability to complete follow-up neurobehavioral assessments.
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
- 観測モデル：COHORT
- 時間の展望：OTHER
コホートと介入
グループ/コホート |
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White matter injure group
Neonates presented with punctate, linear, or clustered white matter lesions at the center of the semiovale and lateral ventricles, with TIWI hyper-intensive s and with or without T2WI hypointensity. |
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Control group
No abnormal signals are found on both conventional and diffusion images. SWI and ASL are also considered when necessary. |
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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Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnosis
時間枠：At 3-5 years of age
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ADHD diagnosis will be determined according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, combined with standardized behavioral assessment using the Swanson, Nolan, and Pelham (SNAP) questionnaire. The number of participants meeting the diagnostic criteria for ADHD at follow-up will be recorded. |
At 3-5 years of age
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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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Cognitive Developmental Outcome
時間枠：During infancy follow-up assessments (6 months to 5 years of age)
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Cognitive development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant Development, Second Edition (BSID-II), Gesell Developmental Schedules, and the Developmental scale for children aged 0~6 years, according to participant age and assessment availability. Cognitive developmental scores will be recorded, and cognitive impairment will be defined according to predefined criteria. The associations between early MRI findings, including semi-quantitative WMI assessment, white matter microstructural features, and structural disconnection measures, and cognitive developmental outcomes will be evaluated. |
During infancy follow-up assessments (6 months to 5 years of age)
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Motor Developmental Outcome
時間枠：During infancy follow-up assessments (6 months to 5 years of age)
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Motor development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant Development, Second Edition (BSID-II), Gesell Developmental Schedules, and the Developmental scale for children aged 0~6 years, according to participant age and assessment availability. Motor developmental scores will be recorded, and motor impairment will be defined according to predefined criteria. The associations between early MRI findings, including semi-quantitative WMI assessment, white matter microstructural features, and structural disconnection measures, and motor developmental outcomes will be evaluated. |
During infancy follow-up assessments (6 months to 5 years of age)
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協力者と研究者
捜査官
- スタディチェア：Jian Yang, Ph.D.,M.D.、First Affiliated Hospital Xi'an Jiaotong University
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
- XJTU1AF-CRF-2020-005
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?
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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