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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02637817

Collaborator

Shenzhen Children's Hospital (Other), General Hospital of Ningxia Medical University (Other), Xijing Hospital (Other), Shengjing Hospital (Other), Second Affiliated Hospital of Wenzhou Medical University (Other), Zunyi Medical College (Other), Shaanxi Provincial People's Hospital (Other), Baoji Central Hospital (Other), Children's Hospital of Fudan University (Other), Hainan People's Hospital (Other)

600

Enrollment

Location

Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Diseases Amblyopia Brain Damage, Chronic Cerebral Palsy

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Control Group Neonates with no evidence of brain lesions on conventional MRI.
Patients Group Neonates with PWML diagnosed by conventional MRI.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 28 Days

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT02637817

Other Study ID Numbers:

2016YFC0100300

First Posted:

Dec 22, 2015

Last Update Posted:

Jun 28, 2018

Last Verified:

Jun 1, 2018

Additional relevant MeSH terms:

Brain Damage, Chronic

Study Results

No Results Posted as of Jun 28, 2018