Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

Congenital Hypothyroidism Clinical Trial

Official title:

Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374593
• Other study ID #: 1401199401
• Status: Completed
• Phase: N/A
• First received: February 18, 2015
• Last updated: October 6, 2017
• Start date: March 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Hypothyroidism
• Hypothyroidism

Intervention

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

Device:
• Ultrasound

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Erica Eugster

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Adjustments	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 number of dose adjustments required per participant during the first 6 months of treatment were recorded.	6 months
Secondary	Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls	Whether the dose adjustment was made for overtreatment was noted as based on TSH and fT4/T4 results	6 months