Clinical Trial: Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

Brief 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.

Detailed Summary:
Sponsor: Erica Eugster

Current Primary Outcome: Thyroid hormones test (thyroid-stimulating hormone (TSH and fT4/T4) [ Time Frame: 6 months ]

Thyroid labs (TSH and fT4/T4) will be monitored per standard care: 2 weeks after initiation of levothyroxine and once monthly during the first 6 months of treatment. Abnormal labs indicating over- and under-treatment will be noted.


Original Primary Outcome: Same as current

Current Secondary Outcome: Time to euthyroidism following diagnosis [ Time Frame: 6 months ]

Thyroid labs (TSH and fT4/T4) will be monitored per standard care: 2 weeks after initiation of levothyroxine and once monthly during the first 6 months of treatment. The time when the patient reaches normal labs with a stable levothyroxine dose will be noted.


Original Secondary Outcome: Same as current

Information By: Indiana University

Dates:
Date Received: February 18, 2015
Date Started: March 2014
Date Completion:
Last Updated: March 21, 2017
Last Verified: March 2017