Background: The initial L-T4 dose currently recommended in the treatment of congenital hypothyroidism (CH) is 1015 mcg/kg per day.
Objective and hypotheses: We designed a multicenter randomized trial to evaluate the effects of different starting doses of L-T4 within the range 1015 mcg/kg per day on neurocognitive development in children with CH.
Method: 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 per day (group A) or 12.615 mcg/kg per day (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 differences in Global and Subscales Quotients between the two groups both at 12 and at 24 months of age.
|Group A||Group B||P|
|Global Developmental Quotient||112.6±22.0||112.1±22.6||Ns|
|Eye-hand coordination Subscale||105.6±12.7||104.5±14.6||Ns|
Conclusion: Different initial doses of L-T4 within the range of 1015 mcg/kg per day are not associated with differences in neurodevelopment and growth during the first two years of life in CH patients.
10 - 12 Sep 2016
European Society for Paediatric Endocrinology