NCT06111456

Acceptability of Expanded Newborn Screening to Parents in France With or Without Genetics in the First Line

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,585 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The recent modifications of the French bioethics law, the therapeutic progress and the massive development of advanced genetic techniques (such Next-Generation Sequencing (NGS)) with a rapid decrease in costs imply to question the extension of Newborn Screening (NBS) to new actionable pathologies and the acceptable and relevant methods for its possible expansion. International studies are beginning to determine the potential place of NGS in NBS. In this perspective, the SeDeN project aims to fully assess the social acceptability of these issues by measuring the diversity and consistency of expectations of French health professionals, parents and public policy makers. The SeDeN-p3 Study focuses on the opinions of parents. It aims to analyze the perception of parents in different situations: birth, early childhood, child screened in the framework of the national neonatal screening program, etc. The objective of this part is to study the understanding and expectations of parents in France regarding the extension of newborn screening as well as their preferences regarding its conditions (information, types of pathologies, screening methods, etc.).

Conditions

• Expanded Newborn Screening
• Parental Acceptability

Interventions

Type	Name	Description
OTHER	Questionnaire	Online self-administered questionnaire to quantitatively mesure parental knowledge and expectations on current and expanded newborn screeing and parental acceptability of expanded newborn screening using genetic.
OTHER	Interview	Semi-structured interview to explore parental representations on the extension of newborn screening and - if concerned - to retrace the screening/diagnosis/care management pathway

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2023-11-01
• Last updated: 2023-11-01

Locations

4 sites across 1 country: France