Evaluation of an Intensified Systematic Screening for Congenital Hypothyroidism in Premature Newborns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood test.
- Who it may be relevant to
- Registry conditions: Congenital Hypothyroidism. Basic parameters: 23 Weeks — 32 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Biological Blood test
routine care blood draw
Primary outcome measures
- Annual incidence of congenital hypothyroidism among premature infants born before 32 weeks of gestational age [Time frame: From birth to Day 15 of life]
Secondary outcome measures (5)
- 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) [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 [Time frame: 15 days at the time of the second sample]
- Effectiveness of the treatment [Time frame: at 2 years of age]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Chu de Lille — Lille
Identifiers
NCT: NCT07425028 · 2022_0207 · 2020-A00437-32