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MRI-Based Neurodevelopmental Risk Stratification in Infants With White Matter Injury

30. září 2026 aktualizováno: First Affiliated Hospital Xi'an Jiaotong University

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Typ studie

Pozorovací

Zápis (Odhadovaný)

260

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Jméno: Jian Yang
Telefonní číslo: +86 18991232396
E-mail: yj1118@mail.xjtu.edu.cn

Studijní místa

Čína
- - Ankang, Čína
    - Ankang Central Hospital
    - Kontakt:
      
      Yukun Liang
      
      Telefonní číslo: +86 0915-3284060
      
      E-mail: 452838744@qq.com
  - Chengdu, Čína
    - Sichuan Provincial Maternity and Child Health Care Hospital
    - Kontakt:
      
      Min Kang
      
      Telefonní číslo: +86 28 8773 8249
      
      E-mail: 1073297610@qq.com
  - Hangzhou, Čína
    - Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
    - Kontakt:
      
      Haibin Wang
      
      Telefonní číslo: +86 0571-56005600
      
      E-mail: haibinw0818@163.com
  - Lanzhou, Čína
    - Gansu Province Maternity and Child Health Hospital
    - Kontakt:
      
      Dalin Zhu
      
      Telefonní číslo: +86 0931-5188888
      
      E-mail: zdlldz@126.com
  - Qinghai, Čína
    - Qinghai Red Cross Hospital
    - Kontakt:
      
      Zhao Feng
      
      Telefonní číslo: +86 0971-8290706
      
      E-mail: feng001zhao@126.com
  - Shanghai, Čína
    - Shanghai Children's Hospital, School of Medicine, Shanghai Jiaotong University
    - Kontakt:
      
      Haoxiang Jiang
      
      Telefonní číslo: +86 021-5297601
      
      E-mail: wyshzl@126.com
  - Shijiazhuang, Čína
    - Hebei Children's Hospital
    - Kontakt:
      
      Shujing Li
      
      Telefonní číslo: +86 0311-85911234
      
      E-mail: lishujing1976@126.com
  - Suzhou, Čína
    - Children's Hospital of Soochow University
    - Kontakt:
      
      WanLiang Guo
      
      Telefonní číslo: +86 0512-80693588
      
      E-mail: gwlsuzhou@163.com
  - Xianyang, Čína
    - The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
    - Kontakt:
      
      Changyi Guo
      
      Telefonní číslo: +86 029-33579191
      
      E-mail: 344952556@qq.com
- Shaanxi
  - Xi'an, Shaanxi, Čína, 710061
    - First Affiliated Hospital of Xi'an Jiaotong University
    - Kontakt:
      
      Jian Yang
      
      Telefonní číslo: +86 18991232396
      
      E-mail: yj1118@mail.xjtu.edu.cn

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

1 den a starší (Dítě, Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Observační modely: COHORT
Časové perspektivy: OTHER

Počet skupin / kohort

Kohorty a intervence

Skupina / kohorta
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.
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

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Adverse neurodevelopmental outcome at 2 Years Časové okno: At 2 Years of Age	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

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Cognitive Developmental Outcome Časové okno: At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age	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
Motor Developmental Outcome Časové okno: At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age	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
Language Developmental Outcome Časové okno: At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age	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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

First Affiliated Hospital Xi'an Jiaotong University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. října 2026

Primární dokončení (Odhadovaný)

1. prosince 2029

Dokončení studie (Odhadovaný)

1. prosince 2030

Termíny zápisu do studia

První předloženo

22. září 2026

První předloženo, které splnilo kritéria kontroly kvality

30. září 2026

První zveřejněno (Aktuální)

6. října 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)