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Starting soon Observational

Evaluation of an Intensified Systematic Screening for Congenital Hypothyroidism in Premature Newborns

NCT07425028 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2027-03
Last updated
2026-05-22

Condition(s) studied

Congenital Hypothyroidism

Investigational drug(s) / intervention(s)

Blood test →

Blood test: routine care blood draw

Study summary

Currently in France, screening for congenital hypothyroidism (CH) in premature infants is done by a single TSH assay on filter paper. However, European recommendations advise repeating the assay within the first month of life.

Our primary objective is to estimate the incidence of CH in preterm infants under 32 weeks of gestational age by applying the European recommendations.

Eligibility

Sex
ALL
Min age
23 Weeks
Max age
32 Weeks
Healthy volunteers
No
Inclusion Criteria: * Newborns born prematurely between 23 and 32 weeks of gestational age (up to 31 weeks and 6 days), both female and male, of all ethnic origins, regardless of birth weight, and including all other pathologies. * Newborns whose parents have given their non-opposition consent. Exclusion Criteria: * Newborns born who leave the region before day 15. * Newborns who die before 15 days of age. * Newborns whose parents are not affiliated with the social security system.

Primary outcome measure(s)

  • Annual incidence of congenital hypothyroidism among premature infants born before 32 weeks of gestational age — From birth to Day 15 of life
    The primary objective of the study is to estimate the annual incidence of congenital hypothyroidism among premature infants born before 32 weeks of gestational age, within 15 days of birth, by applying the European recommendations, which consist of performing two repeated tests within the first 15 days.

Trial sites (1)

FacilityCityRegionStatus
Chu de Lille Lille France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07425028 on ClinicalTrials.gov ↗ ← All trials in France