This randomized controlled trial compared high-dose and moderate-dose levothyroxine as initial therapy for neonates with primary congenital hypothyroidism. One hundred one infants were randomized to receive either approximately 12.85 or 7.65 µg/kg/day. Thyroid function and dose adjustments were assessed every 2 weeks over the first six weeks of treatment to evaluate efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
High-dose Levothyroxine Group (Experimental Arm) Intervention Description: Oral levothyroxine sodium was initiated immediately after diagnosis of primary congenital hypothyroidism at a high initial dose of approximately 10-15 µg/kg/day (mean initial dose: 12.85 ± 1.12 µg/kg/day). The dose was subsequently adjusted according to serial thyroid function tests (TSH and free T4 levels) during follow-up.
Moderate-dose Levothyroxine Group (Active Comparator) Oral levothyroxine sodium was initiated immediately after diagnosis of primary congenital hypothyroidism at a moderate initial dose of approximately 7-9 µg/kg/day (mean initial dose: 7.65 ± 0.56 µg/kg/day). The dose was subsequently adjusted according to serial thyroid function tests (TSH and free T4 levels) during follow-up.
Faculty of Medicine, Menoufia University
Shibīn al Kawm, Menoufia, Egypt
Normalization of thyroid function after two weeks of treatment
Comparison of serum TSH and free T4 between treatment groups after two weeks of levothyroxine therapy.
Time frame: Two weeks
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