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Predicting the Outcome of ADHD in White Matter Injure Neonates With Multi-modality MRI

19. september 2026 oppdatert av: First Affiliated Hospital Xi'an Jiaotong University

Multi-center Longitudinal Clinical Study on the Evolution of Neonatal White Matter Injure to ADHD Based on Multi-modality MRI

The goal of this bidirectional observational cohort study is to investigate the longitudinal relationship between neonatal white matter injury (WMI) and the subsequent development of attention-deficit/hyperactivity disorder (ADHD), and to identify early MRI-based markers associated with ADHD-related outcomes. The study includes both retrospective and prospective cohorts to dynamically evaluate the evolution of brain injury, brain development, and behavioral outcomes from infancy to childhood.

The main questions it aims to answer are:

Are neonatal WMI characteristics associated with the subsequent development of ADHD? Which MRI-derived features, including semi-quantitative WMI assessment, microstructural alterations, and structural disconnection patterns, are associated with ADHD-related outcomes?

Participants with neonatal WMI will undergo longitudinal clinical, neurodevelopmental, and behavioral follow-up. Researchers will analyze clinical information and MRI findings to characterize WMI evolution and identify imaging markers associated with ADHD risk. Participants will:

undergo brain MRI examinations according to clinical protocols; receive standardized neurodevelopmental and behavioral assessments during follow-up; have MRI-derived measures, including semi-quantitative WMI scores, white matter microstructural features, and structural disconnection measures, analyzed to investigate their associations with ADHD-related outcomes.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

White matter injury (WMI) is a common form of neonatal brain injury and may be associated with altered brain development and later neurodevelopmental disorders. Previous studies have suggested that abnormalities in brain microstructure and connectivity after neonatal WMI may overlap with neural circuits involved in attention and executive function. However, the longitudinal evolution of neonatal WMI and its relationship with the development of attention-deficit/hyperactivity disorder (ADHD) remain incompletely understood.

This bidirectional observational cohort study will investigate the association between neonatal WMI characteristics and later ADHD-related outcomes through longitudinal clinical and neuroimaging follow-up. The study includes retrospective and prospective cohorts to characterize brain developmental trajectories after neonatal WMI.

Multimodal MRI analyses were performed to quantify WMI-related brain alterations, including conventional MRI-based semi-quantitative assessment, white matter microstructural measurements, and structural disconnection analysis. These MRI-derived features were evaluated in relation to subsequent neurodevelopmental and behavioral outcomes to identify early imaging markers associated with ADHD risk.

Studietype

Observasjonsmessig

Registrering (Faktiske)

348

Kontakter og plasseringer

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Studiesteder

Kina
- - Hangzhou, Kina
    - Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
  - Lanzhou, Kina
    - Gansu Province Maternity and Child Health Hospital
  - Qinghai, Kina
    - Qinghai Red Cross Hospital
  - Shijiazhuang, Kina
    - Hebei Children's Hospital
  - Suzhou, Kina
    - Children's Hospital of Soochow University
  - Wuxi, Kina
    - Wuxi Children's Hospital
  - Xi'an, Kina
    - Northwest Women's and Children's Hospital
  - Xianyang, Kina
    - The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
- Shaanxi
  - Xi'an, Shaanxi, Kina
    - First Affiliated Hospital of Xi'an Jiaotong University

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

The study population is derived from a multicenter neonatal and infant clinical and multimodal MRI database established through a national research project. The database includes clinical information and multimodal MRI data collected from multiple clinical centers. This bidirectional observational cohort study includes neonates with white matter injury (WMI) identified on brain MRI and control neonates without apparent abnormalities on routine MRI. Eligible participants will be screened from the existing database, and clinical characteristics, MRI findings, and longitudinal neurobehavioral outcomes will be analyzed to investigate the association between neonatal brain injury patterns and later developmental outcomes.

Beskrivelse

Inclusion Criteria:

Neonates diagnosed with white matter injury (WMI) or neonates without obvious abnormalities on routine MRI examination from the multicenter database.
Brain MRI examination performed within 28 days after birth, with gestational age ≤42 weeks at examination.
Complete MRI data available, including T1-weighted imaging (T1WI), T2-weighted imaging (T2WI), and diffusion tensor imaging (DTI).
Complete maternal and pregnancy history information, neonatal demographic characteristics, and clinical information available.

Exclusion Criteria:

Congenital nervous system developmental malformations or suspected genetic or metabolic diseases.
Obvious MRI artifacts affecting image evaluation.
Inability to complete follow-up neurobehavioral assessments.

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
White matter injure group Neonates presented with punctate, linear, or clustered white matter lesions at the center of the semiovale and lateral ventricles, with TIWI hyper-intensive s and with or without T2WI hypointensity.
Control group No abnormal signals are found on both conventional and diffusion images. SWI and ASL are also considered when necessary.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnosis Tidsramme: At 3-5 years of age	ADHD diagnosis will be determined according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, combined with standardized behavioral assessment using the Swanson, Nolan, and Pelham (SNAP) questionnaire. The number of participants meeting the diagnostic criteria for ADHD at follow-up will be recorded.	At 3-5 years of age

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Cognitive Developmental Outcome Tidsramme: During infancy follow-up assessments (6 months to 5 years of age)	Cognitive development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant Development, Second Edition (BSID-II), Gesell Developmental Schedules, and the Developmental scale for children aged 0~6 years, according to participant age and assessment availability. Cognitive developmental scores will be recorded, and cognitive impairment will be defined according to predefined criteria. The associations between early MRI findings, including semi-quantitative WMI assessment, white matter microstructural features, and structural disconnection measures, and cognitive developmental outcomes will be evaluated.	During infancy follow-up assessments (6 months to 5 years of age)
Motor Developmental Outcome Tidsramme: During infancy follow-up assessments (6 months to 5 years of age)	Motor development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant Development, Second Edition (BSID-II), Gesell Developmental Schedules, and the Developmental scale for children aged 0~6 years, according to participant age and assessment availability. Motor developmental scores will be recorded, and motor impairment will be defined according to predefined criteria. The associations between early MRI findings, including semi-quantitative WMI assessment, white matter microstructural features, and structural disconnection measures, and motor developmental outcomes will be evaluated.	During infancy follow-up assessments (6 months to 5 years of age)

Samarbeidspartnere og etterforskere

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Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Etterforskere

Studiestol: Jian Yang, Ph.D.,M.D., First Affiliated Hospital Xi'an Jiaotong University

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 (Faktiske)

29. januar 2023

Primær fullføring (Faktiske)

23. august 2024

Studiet fullført (Faktiske)

30. mai 2025

Datoer for studieregistrering

Først innsendt

28. desember 2022

Først innsendt som oppfylte QC-kriteriene

19. september 2026

Først lagt ut (Faktiske)

23. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)