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Extra blood tests could spot thyroid issues in preemies sooner

NCT ID NCT07425028

Knowledge-focused Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study will check if doing two blood tests instead of one can better detect congenital hypothyroidism in premature babies born before 32 weeks. Researchers will follow 1,600 newborns in France, testing them within 15 days of birth and again at 2 years if needed. The goal is to see if European recommendations for repeat screening catch more cases than the current single-test approach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to improved screening guidelines that catch congenital hypothyroidism earlier in premature babies, preventing developmental delays.
What could go wrong
This is an observational study, not a treatment trial. It only measures how many babies have the condition, so it won't directly improve outcomes. The results may not change current practice if the extra tests don't prove useful.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Premature newborns born in maternity wards included in the study

Ages

23 to 32 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

congenital hypothyroidism Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital hypothyroidism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Chu de Lille

    Lille, France

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