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Newborn Screening for Genetic Susceptibility to Type 1 Diabetes and Celiac Disease and Prospective Follow-up Study

Study acronym: BABYSCREEN
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This is an observational study, in which newborn infants from the general population are screened at birth for HLA-conferred susceptibility to type 1 diabetes and celiac disease. The participants carrying genetic susceptibility to type 1 diabetes (approximately 9.5%) will be analyzed for diabetes-associated autoantibodies at the age of 1, 2 and 3 years, while those predisposed to celiac disease (about 14%) will be screened for tissue transglutaminase antibodies at the age of 1 and 3 years. The intention is to screen annually 10,400 newborn infants for a period of 3 years. About 988 infants are each year identified as a child at risk for type 1 diabetes, and it is expected that around 80% of the families with such a child are willing to join the autoantibody screening. Approximately 1456 infants are each year recognized as a child at risk for celiac disease, and again the expectation is that 80% of the families will join the antibody screening program.
Trial Details
NCT Number NCT04958356
Lead Sponsor University of Helsinki
Conditions
(from sponsor)
Type1diabetes, Celiac Disease
Related terms Celiac Disease, Diabetes Mellitus, Type 1
Enrollment 9,690 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov