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Evaluation of the Expansion of Newborn screening by additional 28 target diseases

Evaluation of the Expansion of Newborn screening by additional 28 target diseases - NGS2025

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025324
Enrollment
800000
Registered
2021-07-13
Start date
2016-08-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Classic homocystinuria Methylmalonaciduria (3 known causes: Mutase deficiency [mut0, mut-], CblA und CblB defects), Combined Methylmalonaciduria und Hyperhomocystinuria resp. isolated remethylation disorder due to a congenital disorder of the vitamin B12 metabolism (8 known causes: Transcobalamin II deficiency, CblC, CblD, CblE, CblF, CblG, CblJ and CblX defects), Methylentetrahydrofolate reductase (MTHFR) deficiency, Neonatal vitamin B12 deficiency, Propionaciduria, Additional urea cycle defec

Interventions

Group 1: Observational study of children with a disease identified in newborn screening and whose diagnosis was subsequently confirmed. According to the study protocol, the following data are recorde

Sponsors

Universitätsklinikum Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

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

Exclusion criteria: No informed consent sample doesnt provide the sufficient amount of material for the analysis

Design outcomes

Primary

MeasureTime frame
• Establishment of a newborn screening for 28 additional target diseases in the Heidelberg newborn screening using second tier strategies • Evaluation of whether a newborn screening for 28 other target diseases fulfills essential criteria for a population screening: o Evaluation of the process quality of the screening process 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

MeasureTime frame
• Evaluation of the medium and long-term medical benefits of screening newborns for additional target diseases by examining the treatment outcome.

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026