UnknownNot Applicable

Pilot Project of Familial Hypercholesterolemia Screening in Newborns in the Czech Republic

Czechia10,000 participantsStarted 2021-07-01

Plain-language summary

The project is a national, prospective, multicenter, non-interventional pilot project of screening for the disease Familial hypercholesterolaemia (FH) in newborns in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Familial hypercholesterolaemia in such a way as to ensure the maximum positive impact on the health of the population and high cost-effectiveness of the whole process.

Who can participate

SexALL

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Inclusion criteria

✓. The mother of the unborn child has a permanent residence in the Czech Republic.
✓. The mother of the unborn child is able to understand the information provided in the Informed Consent and in the Consent to the Processing of Personal Data.

Exclusion criteria

✕. The unborn child suffer from a severe developmental defect. Severe developmental defects are considered to be: severe CNS defect (hydrocephalus, holoprosencephaly), severe heart defect requiring surgical correction, congenital pulmonary airway malformation (CPAM), cystic renal degeneration, GIT obstruction, cleft palate and neural tube defects.
✕. The unborn child suffer from growth retardation (premature babies can be included in the project). Growth retardation is considered to be a growth restriction with a weight estimate below the 5th percentile.
✕. Either of the future parents (mother / father) is diagnosed with FH (or is aware that he or she would suffer from FH).

What they're measuring

Incidence of Familial hypercholesterolaemia in screened cohort of newborns

Timeframe: Until December 31, 2022

Optimal methodological settings for Familial hypercholesterolaemia detection based on combination of both biochemical and molecular-genetic testing made from umbilical cord blood

Timeframe: Until February 28, 2022

Trial details

NCT IDNCT05638022

SponsorInstitute of Health Information and Statistics of the Czech Republic

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2022-12-01

Contact for this trial

Pavel Němec, PhD

+420 777 844 327 pavel.nemec@uzis.cz

View on ClinicalTrials.gov More Familial Hypercholesterolaemia trials