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

NCT07836244 | Completed

• 1 other identifier: XJTU1AF-CRF-2020-005
• Study Type: observational
• Target: 348
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

White Matter Abnormalities, Nonspecific; ADHD; Neurodevelopment Outcome

Keywords

Neonates; Multi-modality MRI; White matter injury; ADHD; punctate white matter lesions

Outcome Measures

Primary Outcomes (1)

• Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnosis

  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

Secondary Outcomes (2)

• Cognitive Developmental Outcome

  During infancy follow-up assessments (6 months to 5 years of age)

• Motor Developmental Outcome

  During infancy follow-up assessments (6 months to 5 years of age)

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (9)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

Hangzhou, China

Location

Gansu Province Maternity and Child Health Hospital

Lanzhou, China

Location

Qinghai Red Cross Hospital

Qinghai, China

Location

Hebei Children's Hospital

Shijiazhuang, China

Location

Children's Hospital of Soochow University

Suzhou, China

Location

Wuxi Children's Hospital

Wuxi, China

Location

Northwest Women's and Children's Hospital

Xi'an, China

Location

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Xianyang, China

Location

MeSH Terms

Conditions

Leukoaraiosis; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jian Yang, Ph.D.,M.D.

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: September 23, 2026
• Study Start: January 29, 2023
• Primary Completion: August 23, 2024
• Study Completion: May 30, 2025
• Last Updated: September 23, 2026

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)