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

NCT02637817 | Unknown

• 1 other identifier: 2016YFC0100300
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Cerebral Palsy

  The enrolled subjects who will be diagnosed as cerebral palsy by clinical examination at age 2.

  At age 2

Secondary Outcomes (1)

• Amblyopia or movement disorder

  At age 3

Study Arms (2)

Control Group

Neonates with no evidence of brain lesions on conventional MRI.

Patients Group

Neonates with PWML diagnosed by conventional MRI.

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

PWML and non-PWML neonates

You may qualify if:

• (1) Age: 1-28 days (2) PWML (3) High quality MRI scan

You may not qualify if:

• (1) Congenital malformations, infections, metabolic disorders, intraventricular hemorrhage (2) Neonates of mothers with gestational diabetes, hypertension, hypoglycemia and history of alcohol

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Shenzhen Children's Hospital: collaborator
• General Hospital of Ningxia Medical University: collaborator
• Xijing Hospital: collaborator
• Shengjing Hospital: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Zunyi Medical College: collaborator
• Shaanxi Provincial People's Hospital: collaborator
• Baoji Central Hospital: collaborator
• Children's Hospital of Fudan University: collaborator
• Hainan People's Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

Related Publications (1)

• Wang M, Liu H, Liu C, Li X, Jin C, Sun Q, Liu Z, Zheng J, Yang J. Prediction of adverse motor outcome for neonates with punctate white matter lesions by MRI images using radiomics strategy: protocol for a prospective cohort multicentre study. BMJ Open. 2019 Apr 3;9(4):e023157. doi: 10.1136/bmjopen-2018-023157.

  PMID: 30948562 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes

Central Study Contacts

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

CONTACT

+8618991232396; cjr.yangjian@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 22, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

CN (1)