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

30 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

260

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Jian Yang
Telefonnummer: +86 18991232396
E-post: yj1118@mail.xjtu.edu.cn

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 dag och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: COHORT
Tidsperspektiv: OTHER

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Adverse neurodevelopmental outcome at 2 Years Tidsram: 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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Cognitive Developmental Outcome Tidsram: 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 Tidsram: 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 Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 december 2029

Avslutad studie (Beräknad)

1 december 2030

Studieregistreringsdatum

Först inskickad

22 september 2026

Först inskickad som uppfyllde QC-kriterierna

30 september 2026

Första postat (Faktisk)

6 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)