MRI-based Biomarkers for Predicting Punctate White Matter... | NCT02637817

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

NCT02637817

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Unknown status

Last Update Posted

Jun 28, 2018Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Brain Diseases
Amblyopia
Brain Damage, Chronic
Cerebral Palsy

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jun 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Dec 18, 2015

First Submission Date that Met QC Criteria

Dec 18, 2015

First Posted Date

Dec 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2018

Last Update Posted Date

Jun 28, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

First Affiliated Hospital Xi'an Jiaotong UniversityOTHER

Collaborators

Name	Class
Shenzhen Children's Hospital	OTHER_GOV
General Hospital of Ningxia Medical University	OTHER
Xijing Hospital	OTHER
Shengjing Hospital

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group		Neonates with no evidence of brain lesions on conventional MRI.
Patients Group		Neonates with PWML diagnosed by conventional MRI.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

28 Days

Standard Ages

Child

Study Population

PWML and non-PWML neonates

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jian Yang, Ph.D.,M.D.	Contact	+8618991232396		cjr.yangjian@vip.163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Xi'an Jiaotong University	Recruiting	Xi'an	Shaanxi		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30948562	Derived	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.

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014786	Vision Disorders
D012678	Sensation Disorders

ID	Term
D001927	Brain Diseases
D000550	Amblyopia
D001925	Brain Damage, Chronic
D002547	Cerebral Palsy