Evaluation of the Expansion of Newborn screening by additional 28 target diseases
Recruiting
- Registration Number
- DRKS00025324
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 800000
Inclusion Criteria
•Newborn in the catchment area of the Newborn screening laboratory Heidelberg ( Newborn which will get a regular screen at the newborn screening laboratory)
•Written consent of at least one parent or caregiver
Exclusion Criteria
No informed consent
sample doesnt provide the sufficient amount of material for the analysis
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Establishment of a newborn screening for 28 additional target diseases in the Heidelberg newborn screening using second tier strategies<br>• Evaluation of whether a newborn screening for 28 other target diseases fulfills essential criteria for a population screening:<br>o Evaluation of the process quality of the screening process<br>o Medical benefit: Determination of the proportion of patients affected by the additionally examined diseases who were diagnosed by the screening before or after the occurrence of disease symptoms
- Secondary Outcome Measures
Name Time Method • Evaluation of the medium and long-term medical benefits of screening newborns for additional target diseases by examining the treatment outcome.