Background: The initial L-T4 dose in the treatment of congenital hypothyroidism (CH) currently recommended is 1015 mcg/kg/die.
Objective: We designed a multicenter randomized trial to evaluate the effects of different starting dose of L-T4 within the range 1015 mcg/kg/die on neurocognitive development in children with CH.
Methods: Seventy-two children with CH diagnosed by neonatal screening were enrolled in the study. They were randomly assigned to receive an initial L-T4 dose of 1012.5 mcg/kg/die (group A) or 12.615 mcg/kg/die (group B). All patients underwent clinical examination and FT4 and TSH measurement periodically during the first two years of life. At the age of 12 and 24 months they underwent Griffiths Mental Development Scales to evaluate cognitive development.
Results: Growth during the first two years of life was comparable in the two groups of patients. Neurodevelopmental evaluation showed no significant difference in Global and Subscales Quotients between the two groups at 12 and at 24 months of age (Table 1).
|Group A||Group B||P|
|Global Developmental Quotient 12 months||105.2±12.6||104.5±12.8||Ns|
|Eye-hand coordination DQ||107.6±17.5||104.4±17.8||Ns|
|Global Developmental Quotient 24 months||96.9±16.6||100.6±16||Ns|
|Eye-hand coordination DQ||100.7±17.5||104.4±13.5||Ns|
Conclusion: Different initial doses of L-T4 within the range of 1015 mcg/kg/die are not associated with differences in neurodevelopment during the first two years of life in CH patients.
18 - 21 May 2019
European Society of Endocrinology