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Study identifier: NCT06549218 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Genetic Newborn Screening for Rare Diseases Within the Screen4Care Project

Condition: Newborn Screening  ·  Sponsor: University Hospital Freiburg

PhaseNA
Planned participants20000
Who can joinAll sexes, N/A to 2 Years
Healthy volunteersYes

About this study

The main objective of the genetic newborn screening part of the Screen4Care-project is to shorten the path to rare disease diagnosis and to facilitate early intervention. Therefore, genetic newborn screening for currently treatable rare diseases (TREAT-panel approach) will be offered to families expecting a baby. Whole genome sequencing (WGS) will be offered as additional diagnostic approach to newborns participating in Screen4Care TREAT-panel approach, if they develop symptoms suggestive of a genetic disease. To evaluate to what extend genetic newborn screening has an impact on participating infants and their families, a follow-up with standardised questionnaires will be performed for all participating families.

This description comes directly from the study's public registry record.

Talk to the study team

Alessandra Ferlini, Professor  ·  +39 0532 974439  ·  screen4care@unife.it

Always discuss trial participation with your own doctor first.

Locations (8)

Centre de Génétique et Centre de Référence Anomalies du Développement et Syndromes Malformatifs, Hôpital d'EnfantsDijon, FranceCompleted
Charité University Medicine BerlinBerlin, GermanyRecruiting
Clinic for Neuropediatrics and Muscular Diseases, Freiburg University Medical CenterFreiburg im Breisgau, GermanyRecruiting
University Medical Center Göttingen, Clinic for NeurologyGöttingen, GermanyRecruiting
Ospedale Pediatrivo Bambino Gesu IRCCSRome, Lazio, ItalyRecruiting
Unit Medical Genetics, Azienda Ospedaliero-Universitaria Sant'AnnaFerrara, ItalyCompleted
Azienda Ospedaliero Universitaria di Modena, Neonatology UnitModena, ItalyRecruiting
San Pietro Fatebenefratelli HospitalRoma, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06549218