Levothyroxine Dosing in Neonatal Congenital Hypothyroidism

Completed · Phase 4

Conditions studied: Congenital Hypothyroidism

In brief

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.

Key facts

Study ID

NCT07754370

Run by

Menoufia University

People needed

101

Starts

2025-11-02

Expected to finish

2026-07-20

Last updated by the study team

2026-08-10

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neonates diagnosed with primary congenital hypothyroidism.
• Full-term infants.
• Newly diagnosed.
• Treatment initiated during the neonatal period.
• Written informed parental consent.

You may not qualify if…

• Central congenital hypothyroidism.
• Prematurity.
• Major congenital malformations.
• Serious systemic illness affecting thyroid function.
• Previously thyroid hormone therapy.

Where it is running

• Faculty of Medicine, Menoufia University — Shibīn al Kawm, Menoufia, Egypt

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.