- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02637817
MRI-based Biomarkers for Predicting Punctate White Matter Lesions in Neonates (PWML)
June 26, 2018 updated by: First Affiliated Hospital Xi'an Jiaotong University
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jian Yang, Ph.D.,M.D.
- Phone Number: +8618991232396
- Email: cjr.yangjian@vip.163.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China
- Recruiting
- First Affiliated Hospital of Xi'an Jiaotong University
-
Contact:
- Jian Yang, Ph.D.,M.D.
- Phone Number: +8618991232396
- Email: cjr.yangjian@vip.163.com
-
-
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
Ages Eligible for Study
1 day to 4 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
PWML and non-PWML neonates
Description
Inclusion Criteria:
-(1) Age: 1-28 days (2) PWML (3) High quality MRI scan
Exclusion Criteria:
-(1) Congenital malformations, infections, metabolic disorders, intraventricular hemorrhage (2) Neonates of mothers with gestational diabetes, hypertension, hypoglycemia and history of alcohol
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: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Control Group
Neonates with no evidence of brain lesions on conventional MRI.
|
Patients Group
Neonates with PWML diagnosed by conventional MRI.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral Palsy
Time Frame: At age 2
|
The enrolled subjects who will be diagnosed as cerebral palsy by clinical examination at age 2.
|
At age 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amblyopia or movement disorder
Time Frame: At age 3
|
The enrolled subjects who will be diagnosed as amblyopia or movement disorder by clinical examination at age 3.
|
At age 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2016
Primary Completion (Anticipated)
June 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
December 18, 2015
First Submitted That Met QC Criteria
December 18, 2015
First Posted (Estimate)
December 22, 2015
Study Record Updates
Last Update Posted (Actual)
June 28, 2018
Last Update Submitted That Met QC Criteria
June 26, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016YFC0100300
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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