Newborn Screening for Aromatic L-amino Acid Decarboxylase... | NCT02399761

Studies
Newborn Screening for Aromatic L-amino Acid Decarboxylase Deficiency

NCT02399761

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Apr 28, 2017Actual

Enrollment

154,795Actual

Phase

Not provided

Conditions

Aromatic L-amino Acid Decarboxylase Deficiency

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Mar 21, 2015

First Submission Date that Met QC Criteria

Mar 25, 2015

First Posted Date

Mar 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2017

Last Update Posted Date

Apr 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Parents of newborns will be invited to test if their newborns are affected with Aromatic L-amino Acid Decarboxylase (AADC) deficiency.

Detailed Description

Parents of newborns will be invited to test if their newborns are affected with Aromatic L-amino Acid Decarboxylase (AADC) deficiency. The routine newborn screening dried blood spots sample will be used to test if 3-O-methyldopa (3-OMD) concentration elevates. If positive of screening test, further confirmation tests including physical examination and for mutation. Genetic counseling and treatment option will be provided, too.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

154,795Actual

Measure	Description	Time Frame
Number of newborns with AADC deficiency		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Babies born in Taiwan receive regular new born 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Months

Standard Ages

Child

Study Population

newborns whose parents agree to be tested

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
C537437	Aromatic amino acid decarboxylase deficiency

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided