Levothyroxine Dosing in Neonatal Congenital Hypothyroidism

Optimizing Initial Levothyroxine Dosing in Neonates With Congenital Hypothyroidism

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07754370

Acronym

CH-LT4

Enrollment

101

Registered

2026-08-10

Start date

2025-11-02

Completion date

2026-07-20

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Hypothyroidism

Keywords

Congenital hypothyroidism; Levothyroxine; Neonatal screening; Randomized controlled trial

Brief 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.

Interventions

DRUGLevothyroxine

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Neonates with primary congenital hypothyroidism were randomized in a 1:1 ratio to receive either a high-dose or moderate-dose of levothyroxine regmen

Eligibility

Sex/Gender

ALL

Age

0 Days to 28 Days

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Normalization of thyroid function after two weeks of treatment	Two weeks	Comparison of serum TSH and free T4 between treatment groups after two weeks of levothyroxine therapy.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026