Resting State Functional Magnetic Resonance Imaging Study... | NCT02224586

Studies
Resting State Functional Magnetic Resonance Imaging Study of Jaundice Infants Before and After Light Treatment.

NCT02224586

Sponsor

Hangzhou Normal University

Status

Unknown status

Last Update Posted

Aug 25, 2014Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Jaundice

Interventions

light treatment

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

Aug 2014

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

Aug 2014

Primary Completion Date

Mar 2015Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

Aug 20, 2014

First Submission Date that Met QC Criteria

Aug 21, 2014

First Posted Date

Aug 25, 2014Estimated

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

Aug 21, 2014

Last Update Posted Date

Aug 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

It is just an observation study. The investigates want to explore the signal changes of resting state functional Magnetic resonance Imaging (fMRI) after light treatment in jaundice infants. Signal changes contain blood oxygenation level dependent (BOLD) and arterial spin labeling (ASL).Indicator of BOLD is amplitude of low-frequency fluctuation（ALFF).Indicator of ASL is cerebral blood flow (CBF).

The investigates assume that the children with jaundice after light therapy, ALFF and CBF will change. Focus on the globus pallidus and subthalamic nuclei. The two brain regions were proved to be abnormal in MRI T1, T2 structure signal in kernicterus.

Doctors observe the status of infants aside.Using monitoring probe can see clearly.

Detailed Description

resting state fMRI scan light therapy the second time resting state fMRI scan

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
light treatment		clinical routine treatment according to the doctor's advice	Device: light treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
light treatment	Device	clinical routine treatment according to the doctor's advice	light treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
amplitude of low-frequency fluctuation change before and after light treatment	It is indicator of blood oxygenation level dependent.	before and after light treatment

Secondary Outcomes

Measure	Description	Time Frame
cerebral blood flow change before after light treatment	It is indicator of arterial spin labeling.	before and after light treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hyperbilirubinemia

Exclusion Criteria:

asphyxia
cerebral dysgenesis

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

municipal hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiao-Bao Xue	Contact			baobao871015@163.com

Overall Officials

Name	Affiliation	Role
Ya-Fei Zhu	Center for Cognition and Brain Disorders,Hangzhou Normal University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Cognition and Brain Disorders	Recruiting	Hangzhou	Zhejiang	311121	China

Condition Browse Module

MeSH Terms

ID	Term
D007565	Jaundice

Ancestor Terms

ID	Term
D006932	Hyperbilirubinemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012877	Skin Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided