- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02952482
Newborn Screening for Adrenoleukodystrophy
July 10, 2018 updated by: National Taiwan University Hospital
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
45796
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
newborns whose parents agree to be tested
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
newborns testing for ALD
|
Routine newborn screening dried blood spots sample is used to test if elevation of C26:0-lyso-PC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
numbers of newborn with ALD
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
October 31, 2016
First Submitted That Met QC Criteria
October 31, 2016
First Posted (Estimate)
November 2, 2016
Study Record Updates
Last Update Posted (Actual)
July 12, 2018
Last Update Submitted That Met QC Criteria
July 10, 2018
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Demyelinating Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Endocrine System Diseases
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Metabolism, Inborn Errors
- Mental Retardation, X-Linked
- Intellectual Disability
- Heredodegenerative Disorders, Nervous System
- Brain Diseases, Metabolic
- Brain Diseases, Metabolic, Inborn
- Leukoencephalopathies
- Adrenal Gland Diseases
- Hereditary Central Nervous System Demyelinating Diseases
- Peroxisomal Disorders
- Adrenal Insufficiency
- Adrenoleukodystrophy
Other Study ID Numbers
- 201603025RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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