An observational study in Congenital Hypothyroidism, sponsored by University Hospital, Lille. Not yet recruiting at 1 site in France. Open to participants aged 23 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by University Hospital, Lille · Observational
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.
Premature newborns born in maternity wards included in the study
Exclusion Criteria:
Newborns born prematurely between 23 and 32 weeks of gestational age (up to 31 weeks and 6 days)
Biological: Blood test
routine care blood draw
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.
Time frame: From birth to Day 15 of life
Rate of patient negative to congenital hypothyroidism (CH) test
Time frame: Day 3
Rate of patient positive to congenital hypothyroidism (CH) test
Time frame: Day 15
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
Time frame: 2 years of age
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.
Time frame: 15 days at the time of the second sample
Effectiveness of the treatment
After discontinuation of L-thyroxine treatment for more than 1 month: measurement of TSH and free T4 (T4L). Results are classified into two categories: TSH \< 5 mIU/L: transient hypothyroidism; (effective treatment) TSH ≥ 5 mIU/L: permanent hypothyroidism.
Time frame: at 2 years of age
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Lille