About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Premature newborns born in maternity wards included in the study
Trial design
Cohort
Prospective
Treatments tested in this trial
Blood test
Biological/Vaccineroutine care blood draw
Treatment groups
Trial outcomes
Primary outcomes
Annual incidence of congenital hypothyroidism among premature infants born before 32 weeks of gestational age
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.
Secondary outcomes
Rate of patient negative to congenital hypothyroidism (CH) test
Rate of patient positive to congenital hypothyroidism (CH) test
persistency of congenital hypothyroidism (CH)
For patients with a positive test on Day 3 or Day 15, an evaluation will be conducted at 2 years of age to determine their status: hypothyroidism yes/no
Association between the risk factors mentioned in the literature (predefined factors) and the presence of congenital hypothyroidism in this population of premature infants
Presence of congenital hypothyroidism detected within the first 15 days of life (at Day 3 or Day 15); risk factors mentioned in the literature: intrauterine growth retardation, gestational age, and peri- or postnatal iodine exposure.
Sponsors and contacts
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