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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00437-32 | Other Identifier | [ID-RCB number, ANSM] |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premature newborn | Newborns born prematurely between 23 and 32 weeks of gestational age (up to 31 weeks and 6 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test | Biological | routine care blood draw |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From birth to Day 15 of life |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Premature newborns born in maternity wards included in the study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine LEFEVRE, MD | Contact | 03.20.44.50.70 | christine.lefevre@chu-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christine LEFEVRE, MD | University Hospital, Lille | Principal Investigator |
| Anais GLUSKO-CHARLET, MD | Arras Hospital Center | Principal Investigator |
| Sylvie MARIETTE, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Lille | Lille | France |
|
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| ID | Term |
|---|---|
| D003409 | Congenital Hypothyroidism |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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whole blood
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 |
| 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. | 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. | at 2 years of age |
| Roubaix Hospital Center |
| Principal Investigator |
| Pierre TOURNEUX, MD | Amiens University Hospital | Principal Investigator |
| D001849 |
| Bone Diseases, Endocrine |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D007037 | Hypothyroidism |
| D013959 | Thyroid Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |