Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

Erica Eugster

Status: Completed

Conditions: Congenital Hypothyroidism

Treatments: Device: Ultrasound; Drug: Levothyroxine

Study type: Interventional

Funder types: Other

Identifiers

NCT02374593

1401199401

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: Under 2 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Targeted dosing

Experimental group

Description:

Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.

Treatment:

Device: Ultrasound

Drug: Levothyroxine