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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Jian Yang
- Número de telefone: +86 18991232396
- E-mail: yj1118@mail.xjtu.edu.cn
Locais de estudo
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Ankang, China
- Ankang Central Hospital
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Contato:
- Yukun Liang
- Número de telefone: +86 0915-3284060
- E-mail: 452838744@qq.com
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Chengdu, China
- Sichuan Provincial Maternity and Child Health Care Hospital
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Contato:
- Min Kang
- Número de telefone: +86 28 8773 8249
- E-mail: 1073297610@qq.com
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Hangzhou, China
- Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
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Contato:
- Haibin Wang
- Número de telefone: +86 0571-56005600
- E-mail: haibinw0818@163.com
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Lanzhou, China
- Gansu Province Maternity and Child Health Hospital
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Contato:
- Dalin Zhu
- Número de telefone: +86 0931-5188888
- E-mail: zdlldz@126.com
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Qinghai, China
- Qinghai Red Cross Hospital
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Contato:
- Zhao Feng
- Número de telefone: +86 0971-8290706
- E-mail: feng001zhao@126.com
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Shanghai, China
- Shanghai Children's Hospital, School of Medicine, Shanghai Jiaotong University
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Contato:
- Haoxiang Jiang
- Número de telefone: +86 021-5297601
- E-mail: wyshzl@126.com
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Shijiazhuang, China
- Hebei Children's Hospital
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Contato:
- Shujing Li
- Número de telefone: +86 0311-85911234
- E-mail: lishujing1976@126.com
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Suzhou, China
- Children's Hospital of Soochow University
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Contato:
- WanLiang Guo
- Número de telefone: +86 0512-80693588
- E-mail: gwlsuzhou@163.com
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Xianyang, China
- The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
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Contato:
- Changyi Guo
- Número de telefone: +86 029-33579191
- E-mail: 344952556@qq.com
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Shaanxi
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Xi'an, Shaanxi, China, 710061
- First Affiliated Hospital of Xi'an Jiaotong University
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Contato:
- Jian Yang
- Número de telefone: +86 18991232396
- E-mail: yj1118@mail.xjtu.edu.cn
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: OTHER
Coortes e Intervenções
Grupo / Coorte |
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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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Adverse neurodevelopmental outcome at 2 Years
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Cognitive Developmental Outcome
Prazo: 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
Prazo: 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
Prazo: 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
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
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- MR-61-26-042984
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