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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02637817

Acronym

PWML

Enrollment

600

Registered

2015-12-22

Start date

2016-01-31

Completion date

2019-12-31

Last updated

2018-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia, Brain Damage, Chronic, Brain Diseases, Cerebral Palsy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactJian Yang, Ph.D.,M.D.

cjr.yangjian@vip.163.com+8618991232396

Outcome results