Brain DiseasesPWMLNCT02637817
MRI-based Biomarkers for Predicting Punctate White Matter Lesions in Neonates
An observational study of Brain Diseases and Amblyopia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
As a common white matter (WM) disease in preterm neonates, punctate white matter lesion (PWML) frequently leads to the abnormalities of brain development (e.g. the motor, visual and auditory disorders), even to cerebral palsy (CP) and amblyopia during childhood. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Brain Diseases, Amblyopia, Brain Damage, Chronic
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2019
- 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 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: PWML and non-PWML neonates
Who may be able to join
- -(1) Age: 1-28 days (2) PWML (3) High quality MRI scan
Who cannot join
- -(1) Congenital malformations, infections, metabolic disorders, intraventricular hemorrhage (2) Neonates of mothers with gestational diabetes, hypertension, hypoglycemia and history of alcohol
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Jian Yang, Ph.D.,M.D., +8618991232396, cjr.yangjian@vip.163.com
About this study
Official title: MRI-based Biomarkers for the Prognosis Judgement of Punctate White Matter Lesions in Neonates: a Longitudinal Multicenter Study
As a common white matter (WM) disease in preterm neonates, punctate white matter lesion (PWML) frequently leads to the abnormalities of brain development (e.g. the motor, visual and auditory disorders), even to cerebral palsy (CP) and amblyopia during childhood. However, it is lack of certain methods in identifying the prognosis of PWML. Through using various advanced MRI techniques, neuro-behavioral and visual assessments, a multicenter longitudinal study would be conducted to follow-up the PWML neonates with varying spatial-position and degree lesions. Through tracking the variations in WM microstructures from neonate period to childhood (2 years old and 3 years old), this study aims to explore (1) the potential relations between varying PWMLs and motor and visual disorders (2) the relations between WM MRI-metrics and neurodevelopmental assessment results, and thus determine the early biomarkers to identify CP and amblyopia.
- Conditions
- Brain Diseases, Amblyopia, Brain Damage, Chronic, Cerebral Palsy
- Medical subject headings
- Brain Diseases, Amblyopia, Brain Damage, Chronic, Cerebral Palsy
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 |
|---|---|---|
| Control Group | Neonates with no evidence of brain lesions on conventional MRI. | |
| Patients Group | Neonates with PWML diagnosed by conventional MRI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Palsy
The enrolled subjects who will be diagnosed as cerebral palsy by clinical examination at age 2.
Measured: At age 2
Secondary outcomes (1)
Amblyopia or movement disorder
The enrolled subjects who will be diagnosed as amblyopia or movement disorder by clinical examination at age 3.
Measured: At age 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain DiseasesStudies 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Children's Hospital, General Hospital of Ningxia Medical University, Xijing Hospital, Shengjing Hospital, Second Affiliated Hospital of Wenzhou Medical University, Zunyi Medical College, Shaanxi Provincial People's Hospital, Baoji Central Hospital, Children's Hospital of Fudan University, Hainan People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637817
- Sponsor's protocol ID
- 2016YFC0100300
- Acronym
- PWML
- Status last verified
- Jun 2018
- First submitted
- 18 Dec 2015
- Last updated
- 28 Jun 2018
- Results posted
- No
Publications
Wang M, Liu H, Liu C, Li X, Jin C, Sun Q, Liu Z, Zheng J, Yang J. Prediction of adverse motor outcome for neonates with punctate white matter lesions by MRI images using radiomics strategy: protocol for a prospective cohort multicentre study. BMJ Open. 2019 Apr 3;9(4):e023157. doi: 10.1136/bmjopen-2018-023157.
PubMed 30948562
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-based Biomarkers for the Prognosis Judgement of Punctate White Matter Lesions in Neonates: a Longitudinal Multicenter Study
- ClinicalTrials.gov ID
- NCT02637817
- Acronym / sponsor ID
- PWML / 2016YFC0100300
- Conditions
- Brain Diseases, Amblyopia, Brain Damage, Chronic, Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Children's Hospital, General Hospital of Ningxia Medical University, Xijing Hospital, Shengjing Hospital, Second Affiliated Hospital of Wenzhou Medical University, Zunyi Medical College, Shaanxi Provincial People's Hospital, Baoji Central Hospital, Children's Hospital of Fudan University, Hainan People's Hospital
- Study start
- Jan 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- 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.
As a common white matter (WM) disease in preterm neonates, punctate white matter lesion (PWML) frequently leads to the abnormalities of brain development (e.g. the motor, visual and auditory disorders), even to cerebral palsy (CP) and amblyopia during childhood. However, it is lack of certain methods in identifying the prognosis of PWML. Through using various advanced MRI techniques, neuro-behavioral and visual assessments, a multicenter longitudinal study would be conducted to follow-up the PWML neonates with varying spatial-position and degree lesions. Through tracking the variations in WM microstructures from neonate period to childhood (2 years old and 3 years old), this study aims to explore (1) the potential relations between varying PWMLs and motor and visual disorders (2) the relations between WM MRI-metrics and neurodevelopmental assessment results, and thus determine the early biomarkers to identify CP and amblyopia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Neonates with no evidence of brain lesions on conventional MRI. |
| Patients Group | – | –Neonates with PWML diagnosed by conventional MRI. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- PWML and non-PWML neonates
Key inclusion criteria (1 listed)
- -(1) Age: 1-28 days (2) PWML (3) High quality MRI scan
Key exclusion criteria (1 listed)
- -(1) Congenital malformations, infections, metabolic disorders, intraventricular hemorrhage (2) Neonates of mothers with gestational diabetes, hypertension, hypoglycemia and history of alcohol
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
Cerebral Palsy
Time frame: At age 2
The enrolled subjects who will be diagnosed as cerebral palsy by clinical examination at age 2.
1 secondary outcome
Amblyopia or movement disorder
Time frame: At age 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Derived from this study: PubMed 30948562Wang M, Liu H, Liu C, Li X, Jin C, Sun Q, Liu Z, Zheng J, Yang J. Prediction of adverse motor outcome for neonates with punctate white matter lesions by MRI images using radiomics strategy: protocol for a prospective cohort multicentre study. BMJ Open. 2019 Apr 3;9(4):e023157. doi: 10.1136/bmjopen-2018-023157.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Diseases and Amblyopia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Yang, Ph.D.,M.D. (+8618991232396, cjr.yangjian@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Palsy (time frame: At age 2). 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 NCT02637817, which also lists 1 linked publication.
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 28 Jun 2018.