Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

30 september 2026 bijgewerkt door: 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:

  1. Which MRI features are associated with adverse neurodevelopmental outcomes in infants with PWML?
  2. 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:

  1. undergo brain MRI examinations according to clinical protocols;
  2. receive standardized neurodevelopmental assessments during follow-up;
  3. have their MRI findings and developmental outcomes analyzed to identify factors associated with later neurodevelopment.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

260

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
      • Ankang, China
        • Ankang Central Hospital
        • Contact:
      • Chengdu, China
        • Sichuan Provincial Maternity and Child Health Care Hospital
        • Contact:
      • Hangzhou, China
        • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
        • Contact:
      • Lanzhou, China
        • Gansu Province Maternity and Child Health Hospital
        • Contact:
      • Qinghai, China
        • Qinghai Red Cross Hospital
        • Contact:
      • Shanghai, China
        • Shanghai Children's Hospital, School of Medicine, Shanghai Jiaotong University
        • Contact:
          • Haoxiang Jiang
          • Telefoonnummer: +86 021-5297601
          • E-mail: wyshzl@126.com
      • Shijiazhuang, China
        • Hebei Children's Hospital
        • Contact:
      • Suzhou, China
        • Children's Hospital of Soochow University
        • Contact:
      • Xianyang, China
        • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 dag en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: OTHER

Cohorten en interventies

Groep / Cohort
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse neurodevelopmental outcome at 2 Years
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cognitive Developmental Outcome
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 december 2029

Studie voltooiing (Geschat)

1 december 2030

Studieregistratiedata

Eerst ingediend

22 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 september 2026

Eerst geplaatst (Werkelijk)

6 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

30 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • MR-61-26-042984

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren