DRKS00034555
Recruiting
Not Applicable
Parent survey on the benefits and burdens of newborn screening
niversitätsklinikum Heidelberg0 sites330 target enrollmentJuly 25, 2024
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- 19 target diseases of newborn screening (NBS) in Germany and 28 additional target diseases of the extended pilot panel as part of the clinical trial NGS 2025 (Heidelberg
- Sponsor
- niversitätsklinikum Heidelberg
- Enrollment
- 330
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For all groups:
- •\- Consenting parents of a child who underwent timely postnatal newborn screening (NBS) including the NGS 2025 pilot study at the screening center in Heidelberg.
- •\- The child's NBS was performed 3\-6 months before study entry.
- •Additional criteria for the different groups:
- •\- Group 1 (parents of newborns with negative NBS): NBS including NGS 2025 showed no abnormalities.
- •\- Group 2 (parents of newborns with false\-positive NBS): The first result of the NBS was abnormal, raising suspicion of a disease targeted by regular screening or the NGS 2025 pilot panel. The suspected diagnosis was not confirmed by the confirmatory diagnostics (biochemical and/or molecular genetic).
- •\- Group 3 (parents of newborns with true\-positive NBS): The first result of the NBS was abnormal, raising suspicion of a disease targeted by regular screening or the NGS 2025 pilot panel. The suspected diagnosis was confirmed biochemically and/or molecularly.
Exclusion Criteria
- •\- Parents of premature babies \< 37\+0 weeks' gestation
- •\- Parents of newborns with a severe general illness or neonatal complications (e. g. respiratory failure, asphyxia, severe neonatal infection) that required hospitalization immediately postpartum
- •\- Parents of newborns for whom newborn screening had to be repeated due to transfusions
- •\- Parents of newborns in whose family a sibling was already diagnosed with a target disease of the NBS before the child was born (high\-risk NBS).
Outcomes
Primary Outcomes
Not specified
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