Newborn Screening for Adrenoleukodystrophy

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Brief Title

Newborn Screening for Adrenoleukodystrophy

Official Title

Newborn Screening for Adrenoleukodystrophy

Brief Summary

      To test if the routine newborn screening dried blood spots can be used to test if elevation
      of C26:0 lysophosphatidylcholine (C26:0-lyso-PC), a status indicating adrenoleukodystrophy
      (ALD)
    

Detailed Description

      Parents of newborns will be invited to test if their newborns are affected with ALD. The
      routine newborn screening dried blood spots sample will be used to test the concentration of
      C26:0-lyso-PC . If positive of a screening test, further confirmation tests including
      physical examination and other methodology for ALD confirmation will be provided. Genetic
      counseling and treatment option will be provided, too.
    


Study Type

Observational


Primary Outcome

numbers of newborn with ALD


Condition

Adrenoleukodystrophy

Intervention

newborns testing for ALD

Study Arms / Comparison Groups

 newborns testing for ALD
Description:  newborns testing for ALD

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

45796

Start Date

November 2016

Completion Date

August 2017

Primary Completion Date

August 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Babies born in Taiwan receive regular newborn screening suggested by Ministry of Heath
             and Welfare.

          -  Parents or Legal Guardian sign in the informed consent form.

        Exclusion Criteria:

          -  Parents or Legal Guardian do not agree to sign in the informed consent form.
      

Gender

All

Ages

N/A - 3 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT02952482

Organization ID

201603025RIND


Responsible Party

Sponsor

Study Sponsor

National Taiwan University Hospital


Study Sponsor

, , 


Verification Date

July 2017