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

30. september 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

260

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 dag og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: COHORT
Tidsperspektiver: OTHER

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / 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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Adverse neurodevelopmental outcome at 2 Years Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Cognitive Developmental Outcome Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. desember 2029

Studiet fullført (Antatt)

1. desember 2030

Datoer for studieregistrering

Først innsendt

22. september 2026

Først innsendt som oppfylte QC-kriteriene

30. september 2026

Først lagt ut (Faktiske)

6. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)