Evaluation of an Intensified Systematic Screening for Congenital Hypothyroidism in Premature Newb… (NCT07425028) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of an Intensified Systematic Screening for Congenital Hypothyroidism in Premature Newborns
France1,600 participantsStarted 2027-03
Plain-language 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.
Who can participate
Age range
23 Weeks – 32 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Annual incidence of congenital hypothyroidism among premature infants born before 32 weeks of gestational age