NCT02224586

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 25, 2014

Status Verified

August 1, 2014

Enrollment Period

7 months

First QC Date

August 20, 2014

Last Update Submit

August 21, 2014

Conditions

Jaundice

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • cerebral blood flow change before after light treatment

    before and after light treatment

Study Arms (1)

light treatment

clinical routine treatment according to the doctor's advice

Device: light treatment

Interventions

light treatmentDEVICE

clinical routine treatment according to the doctor's advice

light treatment

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

municipal hospitals

You may qualify if:

  • hyperbilirubinemia

You may not qualify if:

  • asphyxia
  • cerebral dysgenesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Cognition and Brain Disorders

Hangzhou, Zhejiang, 311121, China

RECRUITING

MeSH Terms

Conditions

Jaundice

Condition Hierarchy (Ancestors)

HyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Ya-Fei Zhu

    Center for Cognition and Brain Disorders,Hangzhou Normal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Bao Xue

CONTACT

baobao871015@163.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 25, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2015

Study Completion

July 1, 2015

Last Updated

August 25, 2014

Record last verified: 2014-08

Locations

CN(1)