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

• Conditions: Amblyopia; Brain Diseases; Brain Damage, Chronic; Cerebral Palsy

• Registration Number: NCT02637817
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-18
• Study First Submitted QC: 2015-12-18
• Study First Posted: 2015-12-22
• Study Start: 2016-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cerebral Palsy	At age 2	The enrolled subjects who will be diagnosed as cerebral palsy by clinical examination at age 2.

Secondary Outcome Measures

Name	Time	Method
Amblyopia or movement disorder	At age 3	The enrolled subjects who will be diagnosed as amblyopia or movement disorder by clinical examination at age 3.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China