Congenital Hypothyroidism
Conditions
Keywords
congenital hypothyroidism, prematurity, screening
Brief 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.
Interventions
BIOLOGICALBlood test
routine care blood draw
Sponsors
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patient negative to congenital hypothyroidism (CH) test | Day 3 | — |
| Rate of patient positive to congenital hypothyroidism (CH) test | Day 15 | — |
| persistency of congenital hypothyroidism (CH) | 2 years of age | 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 | 15 days at the time of the second sample | 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. |
| Effectiveness of the treatment | at 2 years of age | 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. |
Countries
France
Contacts
CONTACTChristine LEFEVRE, MD
PRINCIPAL_INVESTIGATORChristine LEFEVRE, MD
University Hospital, Lille
PRINCIPAL_INVESTIGATORAnais GLUSKO-CHARLET, MD
Arras Hospital Center
PRINCIPAL_INVESTIGATORSylvie MARIETTE, MD
Roubaix Hospital Center
PRINCIPAL_INVESTIGATORPierre TOURNEUX, MD
Amiens University Hospital
Outcome results
None listed