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

2026. szeptember 19. frissítette: 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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Tényleges)

348

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

1 nap és régebbi (Gyermek, Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Megfigyelési modellek: COHORT
Időperspektívák: OTHER

Csoportok/kohorszok száma

Kohorszok és beavatkozások

Csoport / Kohorsz
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnosis Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Cognitive Developmental Outcome Időkeret: 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 Időkeret: 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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

First Affiliated Hospital Xi'an Jiaotong University

Nyomozók

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

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2023. január 29.

Elsődleges befejezés (Tényleges)

2024. augusztus 23.

A tanulmány befejezése (Tényleges)

2025. május 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2022. december 28.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 19.

Első közzététel (Tényleges)

2026. szeptember 23.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)