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| ID | Type | Description | Link |
|---|---|---|---|
| 401 | Other Identifier | AGORA HCL |
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Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent.
In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 < 12 pmol/L and a level of TSH < 15 mUI/L before 15 days of life or < 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THOP treated | Level of circulating T4 < 12 pmol/L at any time of life associated, on the same date, with a level of circulatingon thyro-stimulating hormone < 15 mUI/L if the sample was realiszed before or on the fifteenth day of life OR < 58 mUI/L if the sample was realiszed after the fifteenth day of life, and L-thyroxine treatment is recorded in the medical record (at any dose and with any duration) |
| |
| THOP un-treated | Level of circulating T4 < 12 pmol/L at any time of life associated, on the same date, with a level of circulation thyro-stimulating hormone < 15 mUI/L if sample was realiszed before or on the fifteenth day of life OR < 5 mUI/L if sample was realiszed after the fifteenth day of life, and no L-thyroxine treatment recorded in the medical record. |
| |
| No-THOP | all level of circulating T4 > 12 pmol/L at any time in life |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-thyroxine at a dose of 7.5 µg/kg/d for THOP | Drug | Subjects diagnosed with THOP (as previously defined) and treated with L-thyroxine at a dose of 7.5 µg/kg/d are less likely to have an impaired ASQ score at 4 years of corrected age. |
| Measure | Description | Time Frame |
|---|---|---|
| Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation. | Neuro-development is evaluated routinely by paediatricians during consultation, and this evaluation is reported in medical files. | Evaluation at two years of corrected age. |
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Inclusion Criteria:
Exclusion Criteria:
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Reanimation and intensive care units of neonatology in Auvergne-Rhone Alpes region (Lyon Croix Rousse hospital, Lyon Femme mère Enfant hospital, St Etienne Hopital Nord, Grenoble Hopital couple enfant).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HFME | Bron | 69300 | France | |||
| CHU Grenoble |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| THOP without treatment | Other | Subjects diagnosed with THOP (as previously defined) and who received no L-thyroxine treatment. |
|
| NoTHOP | Other | Subjects diagnosed no-THOP (as previously defined) |
|
| Grenoble |
| 38100 |
| France |
| CHU Saint EtienneHopital | Saint-Etienne | 42000 | France |
| D000091642 | Urogenital Diseases |