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MRI-based Biomarkers for Predicting Punctate White Matter Lesions in Neonates (PWML)

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ClinicalTrials.gov Identifier: NCT02637817
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : August 10, 2016
Sponsor:
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
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief 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. 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.

Condition or disease
Brain Diseases Amblyopia Brain Damage, Chronic Cerebral Palsy

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI-based Biomarkers for the Prognosis Judgement of Punctate White Matter Lesions in Neonates: a Longitudinal Multicenter Study
Study Start Date : January 2016
Estimated Primary Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Control Group
Neonates with no evidence of brain lesions on conventional MRI.
Patients Group
Neonates with PWML diagnosed by conventional MRI.



Primary Outcome Measures :
  1. Cerebral Palsy [ Time Frame: At age 2 ]
    The enrolled subjects who will be diagnosed as cerebral palsy by clinical examination at age 2.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PWML and non-PWML neonates
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637817


Contacts
Contact: Jian Yang, Ph.D.,M.D. +8618991232396 cjr.yangjian@vip.163.com

Locations
China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China
Contact: Jian Yang, Ph.D.,M.D.    +8618991232396    cjr.yangjian@vip.163.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
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: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02637817     History of Changes
Other Study ID Numbers: 2016YFC0100300
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Craniocerebral Trauma
Cerebral Palsy
Amblyopia
Brain Diseases
Brain Injuries
Brain Damage, Chronic
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries