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Clinical Trial Summary

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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT06346236
Study type Observational
Source Hospices Civils de Lyon
Contact
Status Completed
Phase
Start date March 1, 2020
Completion date September 1, 2022

See also
  Status Clinical Trial Phase
Completed NCT03493113 - EEG Alterations in Preterm Infants With Thyroid Dysfunction
Completed NCT05901623 - ASQ Scores of Transient Hypothyroxinemia of Prematurity