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

September 19, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
348

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: OTHER

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnosis
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive Developmental Outcome
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jian Yang, Ph.D.,M.D., First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJTU1AF-CRF-2020-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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