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Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

NCT02374593 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-10-09

Study results available
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Summary

This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as visualized on ultrasound (normal vs. ectopic/sublingual vs. athyreosis) to empiric levothyroxine dosing in infants with congenital hypothyroidism. Patients enrolled in the study for targeted dosing will be compared to controls obtained by retrospective chart review. The main outcome is to determine if there is a difference in the frequency of over-treatment and under-treatment during the first 6 months of therapy.

Conditions

  • Congenital Hypothyroidism

Interventions

DRUG

Levothyroxine

Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound.

DEVICE

Ultrasound

Sponsors & Collaborators

  • Erica Eugster

    lead OTHER

Principal Investigators

  • Erica Eugster, MD · Indiana University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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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 NCT02374593 on ClinicalTrials.gov