Overview

This trial is active, not recruiting.

Condition congenital hypothyroidism
Treatments levothyroxine, ultrasound
Sponsor Erica Eugster
Start date March 2014
End date June 2016
Trial size 40 participants
Trial identifier NCT02374593, 1401199401

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
levothyroxine
Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound.
ultrasound

Primary Outcomes

Measure
Thyroid hormones test (thyroid-stimulating hormone (TSH and fT4/T4)
time frame: 6 months

Secondary Outcomes

Measure
Time to euthyroidism following diagnosis
time frame: 6 months

Eligibility Criteria

Male or female participants up to 2 weeks old.

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.

Additional Information

Official title Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism
Principal investigator Erica Eugster, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Indiana University.