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Newborn Screening for Adrenoleukodystrophy

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Disease Information

Descriptive Information
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 Phase N/A
Study Type † Observational
Study Design † Observational Model: Cohort, Time Perspective: Prospective
Primary Outcome Measure † numbers of newborn with ALD
Secondary Outcome Measure †
Condition † Adrenoleukodystrophy
Intervention † Procedurenewborns testing for ALD
Study Arms / Comparison Groups newborns testing for ALD 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 † 60000
Start Date † November 2016
Completion Date June 2018
Primary Completion Date November 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 Both
Ages N/A - 3 Months
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts †† Yin-Hsiu Chien, M.D., PhD., 223123456, chienyh@ntu.edu.tw
Location Countries † Taiwan
Administrative Information
NCT ID † NCT02952482
Organization ID 201603025RIND
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † National Taiwan University Hospital
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date January 2017
First Received Date † October 31, 2016
Last Updated Date January 5, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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