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

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Xi'an Jiaotong University

Status

Unknown

Conditions

Cerebral Palsy
Amblyopia
Brain Damage, Chronic
Brain Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT02637817
2016YFC0100300

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

1 to 28 days old

Volunteers

No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Jian Yang, Ph.D.,M.D.

Data sourced from clinicaltrials.gov

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