Congenital HypothyroidismPREMATHYRONCT07425028
Evaluation of an Intensified Systematic Screening for Congenital Hypothyroidism in Premature Newborns
An observational study of Congenital Hypothyroidism, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 32 weeks
- Conditions the study is for
- Congenital Hypothyroidism
- What is being tested?
- Blood test
- How many people
- 1,600 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2027to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature newborns born in maternity wards included in the study
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Chu de Lille
Lille
Christine LEFEVRE, MD, 03.20.44.50.70 Ext.+33, christine.lefevre@chu-lille.fr
About this study
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.
- Conditions
- Congenital Hypothyroidism
- Being tested
- Blood test
- Keywords
- congenital hypothyroidism, prematurity, screening
- Medical subject headings
- Congenital Hypothyroidism, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
routine care blood draw
| Study group | Role | What they receive |
|---|---|---|
| Premature newborn | Newborns born prematurely between 23 and 32 weeks of gestational age (up to 31 weeks and 6 days) Receives: Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From birth to Day 15 of life
Secondary outcomes (5)
Rate of patient negative to congenital hypothyroidism (CH) test
Measured: Day 3
Rate of patient positive to congenital hypothyroidism (CH) test
Measured: 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
Measured: 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.
Measured: 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.
Measured: at 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study startMar 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital HypothyroidismStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine LEFEVRE, MD, Principal investigator, University Hospital, LilleAnais GLUSKO-CHARLET, MD, Principal investigator, Arras Hospital CenterSylvie MARIETTE, MD, Principal investigator, Roubaix Hospital CenterPierre TOURNEUX, MD, Principal investigator, Amiens University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425028
- Sponsor's protocol ID
- 2022_0207
- Other IDs
- 2020-A00437-32
- Acronym
- PREMATHYRO
- Status last verified
- May 2026
- First submitted
- 13 Feb 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intensified Systematic Screening for Congenital Hypothyroidism in Premature Newborns
- ClinicalTrials.gov ID
- NCT07425028
- Acronym / sponsor ID
- PREMATHYRO / 2022_0207
- Conditions
- Congenital Hypothyroidism
- Keywords
- congenital hypothyroidism, prematurity, screening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature newborn | – | Biological: Blood testNewborns born prematurely between 23 and 32 weeks of gestational age (up to 31 weeks and 6 days) |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature newborns born in maternity wards included in the study
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testroutine care blood draw | Biological | Premature newborn |
Primary outcome
Annual incidence of congenital hypothyroidism among premature infants born before 32 weeks of gestational age
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine LEFEVRE, MD principal investigator
University Hospital, Lille
Anais GLUSKO-CHARLET, MD principal investigator
Arras Hospital Center
Sylvie MARIETTE, MD principal investigator
Roubaix Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Hypothyroidism, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine LEFEVRE, MD (03.20.44.50.70, christine.lefevre@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual incidence of congenital hypothyroidism among premature infants born before 32 weeks of gestational age (time frame: From birth to Day 15 of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.