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NCT02952482 Clinical Trial

Newborn Screening for Adrenoleukodystrophy

Adrenoleukodystrophy Clinical Trial

Official title:
Newborn Screening for Adrenoleukodystrophy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02952482
Other study ID # 201603025RIND
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2016
Est. completion date August 2017

Study information
Verified date July 2017
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Completed
Enrollment 45796
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 3 Months
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• newborns testing for ALD
Routine newborn screening dried blood spots sample is used to test if elevation of C26:0-lyso-PC

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary numbers of newborn with ALD 12 months
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