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Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Congenital Hypothyroidism

Intervention: Levothyroxine (Drug); Ultrasound (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Erica Eugster

Official(s) and/or principal investigator(s):
Erica Eugster, MD, Principal Investigator, Affiliation: Indiana University

Overall contact:
Melissa Schoelwer, MD, Phone: 317-944-3889, Email: mbauters@iupui.edu


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.

Clinical Details

Official title: Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Thyroid hormones test (thyroid-stimulating hormone (TSH and fT4/T4)

Secondary outcome: Time to euthyroidism following diagnosis


Minimum age: N/A. Maximum age: 2 Weeks. Gender(s): Both.


Inclusion Criteria:

- Newborns diagnosed with congenital hypothyroidism (CH).

- Newborns with CH who are treated by a pediatric endocrinologist at Riley Hospital for

Children or satellite location.

- Newborns with CH who have thyroid imaging performed (thyroid ultrasound or technetium

scan) at diagnosis. Exclusion Criteria:

- Newborns who do not have CH.

- Newborns with CH who have not had thyroid imaging performed at diagnosis.

Locations and Contacts

Melissa Schoelwer, MD, Phone: 317-944-3889, Email: mbauters@iupui.edu

Riley Hospital for Children, Indianapolis, Indiana 46202, United States; Recruiting
Additional Information

Starting date: March 2014
Last updated: March 17, 2015

Page last updated: August 23, 2015

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