Clinical Trial: MRI-based Biomarkers for Predicting Punctate White Matter Lesions in Neonates

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: MRI-based Biomarkers for the Prognosis Judgement of Punctate White Matter Lesions in Neonates: a Longitudinal Multicenter Study

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.

Detailed Summary:
Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: First Affiliated Hospital Xi'an Jiaotong University

Dates:
Date Received: December 18, 2015
Date Started: January 2016
Date Completion:
Last Updated: August 9, 2016
Last Verified: August 2016