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NCT06111456: SeDeN-p3
Acceptability of Expanded Newborn Screening to Parents in France With or Without Genetics in the First Line
trial testing Questionnaire in Expanded Newborn Screening in 1,585 participants. Completed in 1 June 2023.
1 June 2023
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire Dijon |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,585 |
| Start date | 1 September 2022 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 June 2023 |
| Sites | 4 locations across France |
Drugs / interventions tested
- Questionnaire
- Interview
Conditions studied
- Expanded Newborn Screening — all drugs for Expanded Newborn Screening →
- Parental Acceptability — all drugs for Parental Acceptability →
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.
Verify or expand the search:
- PubMed search for NCT06111456
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06111456 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire Dijon
- Last refreshed: 1 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06111456.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing