Punctate White Matter LesionsNCT07860749
MRI-Based Neurodevelopmental Risk Stratification in Infants With White Matter Injury
An observational study of Punctate White Matter Lesions and Neurodevelopmental Outcomes, run by First Affiliated Hospital Xi'an Jiaotong University at 10 sites in China.
Trial summary
The goal of this observational study is to develop and evaluate an MRI-based assessment system for predicting neurodevelopmental outcomes in infants with punctate white matter lesions (PWML). Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Punctate White Matter Lesions, Neurodevelopmental Outcomes, Preterm Infants
- How many people
- 260 participants
- Where
- 10 sitesChina
- Study dates
- Oct 2026to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This study includes infants with punctate white matter lesions (PWML) diagnosed by conventional brain MRI. Eligible participants are infants born at a gestational age of ≥32 weeks and <42 weeks who underwent MRI examination at a corrected gestational age of ≤45 weeks. This multicenter observational cohort study includes retrospective and prospective participants. Clinical information, MRI findings, and longitudinal neurodevelopmental outcomes will be collected to investigate MRI-based assessment methods and predictors of adverse neurodevelopmental outcomes.
Who may be able to join
- Gestational age ≥32 weeks and <42 weeks at birth.
- Brain MRI performed at a corrected gestational age ≤45 weeks.
- Punctate white matter lesions (PWML) diagnosed by conventional brain MRI.
Who cannot join
- Other confirmed brain lesions, such as severe intracranial hemorrhage or cerebral infarction.
- Congenital developmental abnormalities.
- Confirmed genetic or metabolic diseases.
- Conditions that severely affect MRI assessment or neurological/developmental evaluation.
- Inability to complete required MRI assessment or follow-up evaluation.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites
Ankang Central Hospital
Ankang
Yukun Liang, +86 0915-3284060, 452838744@qq.com
Sichuan Provincial Maternity and Child Health Care Hospital
Chengdu
Min Kang, +86 28 8773 8249, 1073297610@qq.com
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou
Haibin Wang, +86 0571-56005600, haibinw0818@163.com
Gansu Province Maternity and Child Health Hospital
Lanzhou
Dalin Zhu, +86 0931-5188888, zdlldz@126.com
Qinghai Red Cross Hospital
Qinghai
Zhao Feng, +86 0971-8290706, feng001zhao@126.com
Shanghai Children's Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai
Haoxiang Jiang, +86 021-5297601, wyshzl@126.com
Hebei Children's Hospital
Shijiazhuang
Shujing Li, +86 0311-85911234, lishujing1976@126.com
Children's Hospital of Soochow University
Suzhou
WanLiang Guo, +86 0512-80693588, gwlsuzhou@163.com
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Jian Yang, +86 18991232396, yj1118@mail.xjtu.edu.cn
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang
Changyi Guo, +86 029-33579191, 344952556@qq.com
About this study
Official title: Multicenter Study for Developing an MRI Assessment System for Neurodevelopmental Risk Stratification in Infants With White Matter Injury
The goal of this observational study is to develop and evaluate an MRI-based assessment system for predicting neurodevelopmental outcomes in infants with punctate white matter lesions (PWML). This is a multicenter, bidirectional cohort study that includes both a retrospective cohort identified from existing clinical and imaging databases and a prospective cohort of consecutively enrolled participants. The study aims to better understand how MRI findings are associated with later developmental outcomes and to identify imaging markers that may help stratify developmental risk.
The main questions it aims to answer are:
Read more
- Which MRI features are associated with adverse neurodevelopmental outcomes in infants with PWML?
- Can MRI-based quantitative assessment methods provide early risk stratification for neurodevelopmental outcomes in infants with PWML?
Participants with PWML diagnosed by brain MRI will be followed and evaluated for neurodevelopmental outcomes. Researchers will analyze clinical information and MRI findings collected from participants to develop and validate prediction models. Participants will:
- undergo brain MRI examinations according to clinical protocols;
- receive standardized neurodevelopmental assessments during follow-up;
- have their MRI findings and developmental outcomes analyzed to identify factors associated with later neurodevelopment.
- Keywords
- Punctate white matter lesions, Preterm infants, Brain MRI, Risk stratification, Neurodevelopment
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 |
|---|---|---|
| Moderate-to-Late Preterm Infants with PWML | This cohort includes infants born at 32 to less than 37 weeks of gestation with punctate white matter lesions diagnosed by brain MRI. Participants will undergo clinical data collection, MRI assessment, and longitudinal neurodevelopmental follow-up to evaluate developmental outcomes. | |
| Term Infants with PWML | This cohort includes infants born at 37 to less than 42 weeks of gestation with punctate white matter lesions diagnosed by brain MRI. Participants will undergo clinical data collection, MRI assessment, and longitudinal neurodevelopmental follow-up to evaluate developmental outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse neurodevelopmental outcome at 2 Years
The percentage of participants with an adverse neurodevelopmental outcome at 2 years of age will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Adverse neurodevelopmental outcome will be defined according to predefined criteria based on developmental assessment scores in the cognitive, motor, and language domains, when available. MRI-derived measures will be analyzed to characterize the extent and pattern of white matter injury and to evaluate their prognostic value for subsequent neurodevelopmental outcomes. These measures will include lesion burden, semiquantitative MRI metrics, DTI-based measures, and structural disconnection measures derived from multimodal MRI.
Measured: At 2 Years of Age
Secondary outcomes (3)
Cognitive Developmental Outcome
Cognitive development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Cognitive impairment will be defined according to predefined score thresholds.The prognostic value of MRI-derived metrics for cognitive impairment will be evaluated. These metrics will include PWML burden, lesion distribution, semi-quantitative metrics, DTI-based measures, and structural disconnection measures.
Measured: At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
Motor Developmental Outcome
Motor development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Motor impairment will be defined according to predefined score thresholds. The prognostic value of MRI-derived metrics for motor impairment will be evaluated. These metrics will include PWML burden, lesion distribution, semi-quantitative metrics, DTI-based measures, and structural disconnection measures.
Measured: At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
Language Developmental Outcome
Language development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, when available and according to the assessment tool and version used at each participating center. Language impairment will be defined according to predefined score thresholds. The prognostic value of MRI-derived metrics for language impairment will be evaluated. These metrics will include PWML burden, lesion distribution, semi-quantitative metrics, DTI-based measures, and structural disconnection measures.
Measured: At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 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 posted6 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Punctate White Matter LesionsStudies of the same condition, open and under way.
- 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860749
- Sponsor's protocol ID
- MR-61-26-042984
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Publications
Wisnowski JL, Wintermark P, Bonifacio SL, Smyser CD, Barkovich AJ, Edwards AD, de Vries LS, Inder TE, Chau V; Newborn Brain Society Guidelines and Publications Committee. Neuroimaging in the term newborn with neonatal encephalopathy. Semin Fetal Neonatal Med. 2021 Oct;26(5):101304. doi: 10.1016/j.siny.2021.101304. Epub 2021 Oct 29.
PubMed 34736808Kennedy E, Guo T, Williams S, Selvanathan T, Alsweiler JM, Bloomfield FH, Battin M, Dubowitz D, Miller SP, Morgan C, Perry D, Stott NS, Harding JE; MR DIAMOND and MoPED Study Groups. Punctate White Matter Abnormality in Moderate-to-Late Preterm Infants. Ann Neurol. 2025 Aug;98(2):329-340. doi: 10.1002/ana.27261. Epub 2025 Jun 9.
PubMed 40488346Mitha A, Chen R, Razaz N, Johansson S, Stephansson O, Altman M, Bolk J. Neurological development in children born moderately or late preterm: national cohort study. BMJ. 2024 Jan 24;384:e075630. doi: 10.1136/bmj-2023-075630.
PubMed 38267070Cayam-Rand D, Guo T, Grunau RE, Benavente-Fernandez I, Synnes A, Chau V, Branson H, Latal B, McQuillen P, Miller SP. Predicting developmental outcomes in preterm infants: A simple white matter injury imaging rule. Neurology. 2019 Sep 24;93(13):e1231-e1240. doi: 10.1212/WNL.0000000000008172. Epub 2019 Aug 29.
PubMed 31467250Guo T, Duerden EG, Adams E, Chau V, Branson HM, Chakravarty MM, Poskitt KJ, Synnes A, Grunau RE, Miller SP. Quantitative assessment of white matter injury in preterm neonates: Association with outcomes. Neurology. 2017 Feb 14;88(7):614-622. doi: 10.1212/WNL.0000000000003606. Epub 2017 Jan 18.
PubMed 28100727Hayman M, van Wezel-Meijler G, van Straaten H, Brilstra E, Groenendaal F, de Vries LS. Punctate white-matter lesions in the full-term newborn: Underlying aetiology and outcome. Eur J Paediatr Neurol. 2019 Mar;23(2):280-287. doi: 10.1016/j.ejpn.2019.01.005. Epub 2019 Jan 26.
PubMed 30744982Inder TE, Volpe JJ, Anderson PJ. Defining the Neurologic Consequences of Preterm Birth. N Engl J Med. 2023 Aug 3;389(5):441-453. doi: 10.1056/NEJMra2303347. No abstract available.
PubMed 37530825Rees P, Callan C, Chadda KR, Vaal M, Diviney J, Sabti S, Harnden F, Gardiner J, Battersby C, Gale C, Sutcliffe A. Preterm Brain Injury and Neurodevelopmental Outcomes: A Meta-analysis. Pediatrics. 2022 Dec 1;150(6):e2022057442. doi: 10.1542/peds.2022-057442.
PubMed 36330752
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study for Developing an MRI Assessment System for Neurodevelopmental Risk Stratification in Infants With White Matter Injury
- ClinicalTrials.gov ID
- NCT07860749
- Acronym / sponsor ID
- MR-61-26-042984
- Keywords
- Punctate white matter lesions, Preterm infants, Brain MRI, Risk stratification, Neurodevelopment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 6 Oct 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 observational study is to develop and evaluate an MRI-based assessment system for predicting neurodevelopmental outcomes in infants with punctate white matter lesions (PWML). This is a multicenter, bidirectional cohort study that includes both a retrospective cohort identified from existing clinical and imaging databases and a prospective cohort of consecutively enrolled participants. The study aims to better understand how MRI findings are associated with later developmental outcomes and to identify imaging markers that may help stratify developmental risk.
The main questions it aims to answer are:
- Which MRI features are associated with adverse neurodevelopmental outcomes in infants with PWML?
- Can MRI-based quantitative assessment methods provide early risk stratification for neurodevelopmental outcomes in infants with PWML?
Participants with PWML diagnosed by brain MRI will be followed and evaluated for neurodevelopmental outcomes. Researchers will analyze clinical information and MRI findings collected from participants to develop and validate prediction models. Participants will:
- undergo brain MRI examinations according to clinical protocols;
- receive standardized neurodevelopmental assessments during follow-up;
- have their MRI findings and developmental outcomes analyzed to identify factors associated with later neurodevelopment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-Late Preterm Infants with PWML | – | –This cohort includes infants born at 32 to less than 37 weeks of gestation with punctate white matter lesions diagnosed by brain MRI. Participants will undergo clinical data collection, MRI assessment, and longitudinal neurodevelopmental follow-up to evaluate developmental outcomes. |
| Term Infants with PWML | – | –This cohort includes infants born at 37 to less than 42 weeks of gestation with punctate white matter lesions diagnosed by brain MRI. Participants will undergo clinical data collection, MRI assessment, and longitudinal neurodevelopmental follow-up to evaluate developmental outcome |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study includes infants with punctate white matter lesions (PWML) diagnosed by conventional brain MRI. Eligible participants are infants born at a gestational age of ≥32 weeks and <42 weeks who underwent MRI examination at a corrected gestational age of ≤45 weeks. This multicenter observational cohort study includes retrospective and prospective participants. Clinical information, MRI findings, and longitudinal neurodevelopmental outcomes will be collected to investigate MRI-based assessment methods and predictors of adverse neurodevelopmental outcomes.
Key inclusion criteria (3 listed)
- Gestational age ≥32 weeks and <42 weeks at birth.
- Brain MRI performed at a corrected gestational age ≤45 weeks.
- Punctate white matter lesions (PWML) diagnosed by conventional brain MRI.
Key exclusion criteria (5 listed)
- Other confirmed brain lesions, such as severe intracranial hemorrhage or cerebral infarction.
- Congenital developmental abnormalities.
- Confirmed genetic or metabolic diseases.
- Conditions that severely affect MRI assessment or neurological/developmental evaluation.
- Inability to complete required MRI assessment or follow-up evaluation.
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
Adverse neurodevelopmental outcome at 2 Years
Time frame: At 2 Years of Age
The percentage of participants with an adverse neurodevelopmental outcome at 2 years of age will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Adverse neurodevelopmental outcome will be defined according to predefined criteria based on developmental assessment scores in the cognitive, motor, and language domains, when available. MRI-derived measures will be analyzed to characterize the extent and pattern of white matter injury and to evaluate their prognostic value for subsequent neurodevelopmental outcomes. These measures will include lesion burden, semiquantitative MRI metrics, DTI-based measures, and structural disconnection measures derived from multimodal MRI.
3 secondary outcomes
Cognitive Developmental Outcome
Time frame: At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
Motor Developmental Outcome
Time frame: At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
Language Developmental Outcome
Time frame: At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Results publication: PubMed 34736808Wisnowski JL, Wintermark P, Bonifacio SL, Smyser CD, Barkovich AJ, Edwards AD, de Vries LS, Inder TE, Chau V; Newborn Brain Society Guidelines and Publications Committee. Neuroimaging in the term newborn with neonatal encephalopathy. Semin Fetal Neonatal Med. 2021 Oct;26(5):101304. doi: 10.1016/j.siny.2021.101304. Epub 2021 Oct 29.
- Results publication: PubMed 40488346Kennedy E, Guo T, Williams S, Selvanathan T, Alsweiler JM, Bloomfield FH, Battin M, Dubowitz D, Miller SP, Morgan C, Perry D, Stott NS, Harding JE; MR DIAMOND and MoPED Study Groups. Punctate White Matter Abnormality in Moderate-to-Late Preterm Infants. Ann Neurol. 2025 Aug;98(2):329-340. doi: 10.1002/ana.27261. Epub 2025 Jun 9.
- Results publication: PubMed 38267070Mitha A, Chen R, Razaz N, Johansson S, Stephansson O, Altman M, Bolk J. Neurological development in children born moderately or late preterm: national cohort study. BMJ. 2024 Jan 24;384:e075630. doi: 10.1136/bmj-2023-075630.
- Results publication: PubMed 31467250Cayam-Rand D, Guo T, Grunau RE, Benavente-Fernandez I, Synnes A, Chau V, Branson H, Latal B, McQuillen P, Miller SP. Predicting developmental outcomes in preterm infants: A simple white matter injury imaging rule. Neurology. 2019 Sep 24;93(13):e1231-e1240. doi: 10.1212/WNL.0000000000008172. Epub 2019 Aug 29.
- Results publication: PubMed 28100727Guo T, Duerden EG, Adams E, Chau V, Branson HM, Chakravarty MM, Poskitt KJ, Synnes A, Grunau RE, Miller SP. Quantitative assessment of white matter injury in preterm neonates: Association with outcomes. Neurology. 2017 Feb 14;88(7):614-622. doi: 10.1212/WNL.0000000000003606. Epub 2017 Jan 18.
- Results publication: PubMed 30744982Hayman M, van Wezel-Meijler G, van Straaten H, Brilstra E, Groenendaal F, de Vries LS. Punctate white-matter lesions in the full-term newborn: Underlying aetiology and outcome. Eur J Paediatr Neurol. 2019 Mar;23(2):280-287. doi: 10.1016/j.ejpn.2019.01.005. Epub 2019 Jan 26.
- Results publication: PubMed 37530825Inder TE, Volpe JJ, Anderson PJ. Defining the Neurologic Consequences of Preterm Birth. N Engl J Med. 2023 Aug 3;389(5):441-453. doi: 10.1056/NEJMra2303347. No abstract available.
- Results publication: PubMed 36330752Rees P, Callan C, Chadda KR, Vaal M, Diviney J, Sabti S, Harnden F, Gardiner J, Battersby C, Gale C, Sutcliffe A. Preterm Brain Injury and Neurodevelopmental Outcomes: A Meta-analysis. Pediatrics. 2022 Dec 1;150(6):e2022057442. doi: 10.1542/peds.2022-057442.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Punctate White Matter Lesions and Neurodevelopmental Outcomes, run by First Affiliated Hospital Xi'an Jiaotong University at 10 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Yang (+86 18991232396, yj1118@mail.xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse neurodevelopmental outcome at 2 Years (time frame: At 2 Years of Age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07860749, which also lists 8 linked publications.
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 6 Oct 2026.