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

30 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

260

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
      • Ankang, Chine
        • Ankang Central Hospital
        • Contact:
      • Chengdu, Chine
        • Sichuan Provincial Maternity and Child Health Care Hospital
        • Contact:
      • Hangzhou, Chine
        • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
        • Contact:
      • Lanzhou, Chine
        • Gansu Province Maternity and Child Health Hospital
        • Contact:
          • Dalin Zhu
          • Numéro de téléphone: +86 0931-5188888
          • E-mail: zdlldz@126.com
      • Qinghai, Chine
        • Qinghai Red Cross Hospital
        • Contact:
      • Shanghai, Chine
        • Shanghai Children's Hospital, School of Medicine, Shanghai Jiaotong University
        • Contact:
          • Haoxiang Jiang
          • Numéro de téléphone: +86 021-5297601
          • E-mail: wyshzl@126.com
      • Shijiazhuang, Chine
        • Hebei Children's Hospital
        • Contact:
      • Suzhou, Chine
        • Children's Hospital of Soochow University
        • Contact:
      • Xianyang, Chine
        • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, Chine, 710061
        • First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 jour et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: OTHER

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Adverse neurodevelopmental outcome at 2 Years
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cognitive Developmental Outcome
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

First Affiliated Hospital Xi'an Jiaotong University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 décembre 2029

Achèvement de l'étude (Estimé)

1 décembre 2030

Dates d'inscription aux études

Première soumission

22 septembre 2026

Première soumission répondant aux critères de contrôle qualité

30 septembre 2026

Première publication (Réel)

6 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • MR-61-26-042984

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

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