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

Cerebral Palsy Clinical Trial

— PWML  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02637817
• Other study ID #: 2016YFC0100300
• Status: Recruiting
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: June 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jian Yang, Ph.D.,M.D.
• Phone: +8618991232396
• Email: cjr.yangjian[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (11)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Baoji Central Hospital, Children's Hospital of Fudan University, General Hospital of Ningxia Medical University, Hainan People's Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shaanxi Provincial People's Hospital, Shengjing Hospital, Shenzhen Children's Hospital, Xijing Hospital, Zunyi Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Palsy	The enrolled subjects who will be diagnosed as cerebral palsy by clinical examination at age 2.	At age 2
Secondary	Amblyopia or movement disorder	The enrolled subjects who will be diagnosed as amblyopia or movement disorder by clinical examination at age 3.	At age 3