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NCT06111456: SeDeN-p3

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

Completed Last updated 1 November 2023
What this trial tests

trial testing Questionnaire in Expanded Newborn Screening in 1,585 participants. Completed in 1 June 2023.

Timeline
1 September 2022
Primary endpoint
1 June 2023
1 June 2023

Quick facts

Lead sponsorCentre Hospitalier Universitaire Dijon
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,585
Start date1 September 2022
Primary completion1 June 2023
Estimated completion1 June 2023
Sites4 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

Adults 18 to 60, any sex, with Expanded Newborn Screening or Parental Acceptability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

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