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Levothyroxine Dosing in Neonatal Congenital Hypothyroidism
Sponsor: Menoufia University
Summary
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.
Official title: Optimizing Initial Levothyroxine Dosing in Neonates With Congenital Hypothyroidism
Key Details
Gender
All
Age Range
0 Days - 28 Days
Study Type
INTERVENTIONAL
Enrollment
101
Start Date
2025-11-02
Completion Date
2026-07-20
Last Updated
2026-08-10
Healthy Volunteers
No
Conditions
Interventions
Levothyroxine
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.
Levothyroxine
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.
Locations (1)
Faculty of Medicine, Menoufia University
Shibīn al Kawm, Menoufia, Egypt