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Levothyroxine Dosing in Neonatal Congenital Hypothyroidism

NCT07754370 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2026-08-10

No results posted yet for this study

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.

Conditions

  • Congenital Hypothyroidism

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Menoufia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-02
Primary Completion
2026-07-20
Completion
2026-07-20

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754370 on ClinicalTrials.gov