Levothyroxine Dosing in Neonatal Congenital Hypothyroidism

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.

NCT Number	NCT07754370
Lead Sponsor	Menoufia University
Conditions	Congenital Hypothyroidism
Enrollment	101 participants
Start Date	2025-11-02
Primary Completion	2026-07-20 (estimated)
Study Completion	2026-07-20 (estimated)
Updated on ClinicalTrials.gov	2026-08-10