MRI-Based Neurodevelopmental Risk Stratification in Infants With White Matter Injury
Multicenter Study for Developing an MRI Assessment System for Neurodevelopmental Risk Stratification in Infants With White Matter Injury
The goal of this observational study is to develop and evaluate an MRI-based assessment system for predicting neurodevelopmental outcomes in infants with punctate white matter lesions (PWML). This is a multicenter, bidirectional cohort study that includes both a retrospective cohort identified from existing clinical and imaging databases and a prospective cohort of consecutively enrolled participants. The study aims to better understand how MRI findings are associated with later developmental outcomes and to identify imaging markers that may help stratify developmental risk.
The main questions it aims to answer are:
- Which MRI features are associated with adverse neurodevelopmental outcomes in infants with PWML?
- Can MRI-based quantitative assessment methods provide early risk stratification for neurodevelopmental outcomes in infants with PWML?
Participants with PWML diagnosed by brain MRI will be followed and evaluated for neurodevelopmental outcomes. Researchers will analyze clinical information and MRI findings collected from participants to develop and validate prediction models. Participants will:
- undergo brain MRI examinations according to clinical protocols;
- receive standardized neurodevelopmental assessments during follow-up;
- have their MRI findings and developmental outcomes analyzed to identify factors associated with later neurodevelopment.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jian Yang
- 電話番号：+86 18991232396
- メール：yj1118@mail.xjtu.edu.cn
研究場所
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Ankang、中国
- Ankang Central Hospital
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コンタクト：
- Yukun Liang
- 電話番号：+86 0915-3284060
- メール：452838744@qq.com
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Chengdu、中国
- Sichuan Provincial Maternity and Child Health Care Hospital
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コンタクト：
- Min Kang
- 電話番号：+86 28 8773 8249
- メール：1073297610@qq.com
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Hangzhou、中国
- Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
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コンタクト：
- Haibin Wang
- 電話番号：+86 0571-56005600
- メール：haibinw0818@163.com
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Lanzhou、中国
- Gansu Province Maternity and Child Health Hospital
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コンタクト：
- Dalin Zhu
- 電話番号：+86 0931-5188888
- メール：zdlldz@126.com
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Qinghai、中国
- Qinghai Red Cross Hospital
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コンタクト：
- Zhao Feng
- 電話番号：+86 0971-8290706
- メール：feng001zhao@126.com
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Shanghai、中国
- Shanghai Children's Hospital, School of Medicine, Shanghai Jiaotong University
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コンタクト：
- Haoxiang Jiang
- 電話番号：+86 021-5297601
- メール：wyshzl@126.com
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Shijiazhuang、中国
- Hebei Children's Hospital
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コンタクト：
- Shujing Li
- 電話番号：+86 0311-85911234
- メール：lishujing1976@126.com
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Suzhou、中国
- Children's Hospital of Soochow University
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コンタクト：
- WanLiang Guo
- 電話番号：+86 0512-80693588
- メール：gwlsuzhou@163.com
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Xianyang、中国
- The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
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コンタクト：
- Changyi Guo
- 電話番号：+86 029-33579191
- メール：344952556@qq.com
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Shaanxi
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Xi'an、Shaanxi、中国、710061
- First Affiliated Hospital of Xi'an Jiaotong University
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コンタクト：
- Jian Yang
- 電話番号：+86 18991232396
- メール：yj1118@mail.xjtu.edu.cn
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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
This study includes infants with punctate white matter lesions (PWML) diagnosed by conventional brain MRI. Eligible participants are infants born at a gestational age of ≥32 weeks and <42 weeks who underwent MRI examination at a corrected gestational age of ≤45 weeks. This multicenter observational cohort study includes retrospective and prospective participants. Clinical information, MRI findings, and longitudinal neurodevelopmental outcomes will be collected to investigate MRI-based assessment methods and predictors of adverse neurodevelopmental outcomes.
説明
Inclusion Criteria:
- Gestational age ≥32 weeks and <42 weeks at birth.
- Brain MRI performed at a corrected gestational age ≤45 weeks.
- Punctate white matter lesions (PWML) diagnosed by conventional brain MRI.
Exclusion Criteria:
- Other confirmed brain lesions, such as severe intracranial hemorrhage or cerebral infarction.
- Congenital developmental abnormalities.
- Confirmed genetic or metabolic diseases.
- Conditions that severely affect MRI assessment or neurological/developmental evaluation.
- Inability to complete required MRI assessment or follow-up evaluation.
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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Moderate-to-Late Preterm Infants with PWML
This cohort includes infants born at 32 to less than 37 weeks of gestation with punctate white matter lesions diagnosed by brain MRI. Participants will undergo clinical data collection, MRI assessment, and longitudinal neurodevelopmental follow-up to evaluate developmental outcomes. |
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Term Infants with PWML
This cohort includes infants born at 37 to less than 42 weeks of gestation with punctate white matter lesions diagnosed by brain MRI. Participants will undergo clinical data collection, MRI assessment, and longitudinal neurodevelopmental follow-up to evaluate developmental outcome |
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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Adverse neurodevelopmental outcome at 2 Years
時間枠：At 2 Years of Age
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The percentage of participants with an adverse neurodevelopmental outcome at 2 years of age will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Adverse neurodevelopmental outcome will be defined according to predefined criteria based on developmental assessment scores in the cognitive, motor, and language domains, when available. MRI-derived measures will be analyzed to characterize the extent and pattern of white matter injury and to evaluate their prognostic value for subsequent neurodevelopmental outcomes. These measures will include lesion burden, semiquantitative MRI metrics, DTI-based measures, and structural disconnection measures derived from multimodal MRI. |
At 2 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：At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
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Cognitive development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Cognitive impairment will be defined according to predefined score thresholds.The prognostic value of MRI-derived metrics for cognitive impairment will be evaluated. These metrics will include PWML burden, lesion distribution, semi-quantitative metrics, DTI-based measures, and structural disconnection measures. |
At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
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Motor Developmental Outcome
時間枠：At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
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Motor development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Motor impairment will be defined according to predefined score thresholds. The prognostic value of MRI-derived metrics for motor impairment will be evaluated. These metrics will include PWML burden, lesion distribution, semi-quantitative metrics, DTI-based measures, and structural disconnection measures. |
At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
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Language Developmental Outcome
時間枠：At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
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Language development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, when available and according to the assessment tool and version used at each participating center. Language impairment will be defined according to predefined score thresholds. The prognostic value of MRI-derived metrics for language impairment will be evaluated. These metrics will include PWML burden, lesion distribution, semi-quantitative metrics, DTI-based measures, and structural disconnection measures. |
At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Wisnowski JL, Wintermark P, Bonifacio SL, Smyser CD, Barkovich AJ, Edwards AD, de Vries LS, Inder TE, Chau V; Newborn Brain Society Guidelines and Publications Committee. Neuroimaging in the term newborn with neonatal encephalopathy. Semin Fetal Neonatal Med. 2021 Oct;26(5):101304. doi: 10.1016/j.siny.2021.101304. Epub 2021 Oct 29.
- Kennedy E, Guo T, Williams S, Selvanathan T, Alsweiler JM, Bloomfield FH, Battin M, Dubowitz D, Miller SP, Morgan C, Perry D, Stott NS, Harding JE; MR DIAMOND and MoPED Study Groups. Punctate White Matter Abnormality in Moderate-to-Late Preterm Infants. Ann Neurol. 2025 Aug;98(2):329-340. doi: 10.1002/ana.27261. Epub 2025 Jun 9.
- Mitha A, Chen R, Razaz N, Johansson S, Stephansson O, Altman M, Bolk J. Neurological development in children born moderately or late preterm: national cohort study. BMJ. 2024 Jan 24;384:e075630. doi: 10.1136/bmj-2023-075630.
- Cayam-Rand D, Guo T, Grunau RE, Benavente-Fernandez I, Synnes A, Chau V, Branson H, Latal B, McQuillen P, Miller SP. Predicting developmental outcomes in preterm infants: A simple white matter injury imaging rule. Neurology. 2019 Sep 24;93(13):e1231-e1240. doi: 10.1212/WNL.0000000000008172. Epub 2019 Aug 29.
- Guo T, Duerden EG, Adams E, Chau V, Branson HM, Chakravarty MM, Poskitt KJ, Synnes A, Grunau RE, Miller SP. Quantitative assessment of white matter injury in preterm neonates: Association with outcomes. Neurology. 2017 Feb 14;88(7):614-622. doi: 10.1212/WNL.0000000000003606. Epub 2017 Jan 18.
- Hayman M, van Wezel-Meijler G, van Straaten H, Brilstra E, Groenendaal F, de Vries LS. Punctate white-matter lesions in the full-term newborn: Underlying aetiology and outcome. Eur J Paediatr Neurol. 2019 Mar;23(2):280-287. doi: 10.1016/j.ejpn.2019.01.005. Epub 2019 Jan 26.
- Inder TE, Volpe JJ, Anderson PJ. Defining the Neurologic Consequences of Preterm Birth. N Engl J Med. 2023 Aug 3;389(5):441-453. doi: 10.1056/NEJMra2303347. No abstract available.
- Rees P, Callan C, Chadda KR, Vaal M, Diviney J, Sabti S, Harnden F, Gardiner J, Battersby C, Gale C, Sutcliffe A. Preterm Brain Injury and Neurodevelopmental Outcomes: A Meta-analysis. Pediatrics. 2022 Dec 1;150(6):e2022057442. doi: 10.1542/peds.2022-057442.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
その他の研究ID番号
- MR-61-26-042984
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