NCT02399761

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154,795

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 28, 2017

Status Verified

October 1, 2016

Enrollment Period

3.9 years

First QC Date

March 21, 2015

Last Update Submit

April 26, 2017

Conditions

Aromatic L-amino Acid Decarboxylase Deficiency

Keywords

AADC deficiency, newborn screening

Outcome Measures

Primary Outcomes (1)

  • Number of newborns with AADC deficiency

    3 years

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

newborns whose parents agree to be tested

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Aromatic amino acid decarboxylase deficiency

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2015

First Posted

March 26, 2015

Study Start

August 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 28, 2017

Record last verified: 2016-10

Locations

TW(1)