White Matter Abnormalities, NonspecificNCT07836244
Predicting the Outcome of ADHD in White Matter Injure Neonates With Multi-modality MRI
An observational study of White Matter Abnormalities, Nonspecific and ADHD, run by First Affiliated Hospital Xi'an Jiaotong University at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- White Matter Abnormalities, Nonspecific, ADHD, Neurodevelopment Outcome
- How many people
- 348 participants
- Where
- 9 sitesChina
- Study dates
- 29 Jan 2023to 30 May 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Congenital nervous system developmental malformations or suspected genetic or metabolic diseases.
- Obvious MRI artifacts affecting image evaluation.
- Inability to complete follow-up neurobehavioral assessments.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou
Gansu Province Maternity and Child Health Hospital
Lanzhou
Qinghai Red Cross Hospital
Qinghai
Hebei Children's Hospital
Shijiazhuang
Children's Hospital of Soochow University
Suzhou
Wuxi Children's Hospital
Wuxi
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Northwest Women's and Children's Hospital
Xi'an
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang
About this study
Official title: 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:
Read more
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.
Read the 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.
- Keywords
- Neonates, Multi-modality MRI, White matter injury, ADHD, punctate white matter lesions
- Medical subject headings
- Leukoaraiosis, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3-5 years of age
Secondary outcomes (2)
Cognitive Developmental Outcome
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.
Measured: During infancy follow-up assessments (6 months to 5 years of age)
Motor Developmental Outcome
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.
Measured: During infancy follow-up assessments (6 months to 5 years of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start29 Jan 2023
- Primary completion23 Aug 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Matter Abnormalities, NonspecificStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 348 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Yang, Ph.D.,M.D., Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836244
- Sponsor's protocol ID
- XJTU1AF-CRF-2020-005
- Status last verified
- Dec 2022
- First submitted
- 28 Dec 2022
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Longitudinal Clinical Study on the Evolution of Neonatal White Matter Injure to ADHD Based on Multi-modality MRI
- ClinicalTrials.gov ID
- NCT07836244
- Acronym / sponsor ID
- XJTU1AF-CRF-2020-005
- Keywords
- Neonates, Multi-modality MRI, White matter injury, ADHD, punctate white matter lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 29 Jan 2023 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Congenital nervous system developmental malformations or suspected genetic or metabolic diseases.
- Obvious MRI artifacts affecting image evaluation.
- Inability to complete follow-up neurobehavioral assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Cognitive Developmental Outcome
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Yang, Ph.D.,M.D. study chair
First Affiliated Hospital Xi'an Jiaotong University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of White Matter Abnormalities, Nonspecific and ADHD, run by First Affiliated Hospital Xi'an Jiaotong University at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnosis (time frame: At 3-5 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.