Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Hypothyroidism Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Endocrine System Diseases Genetic Diseases, Inborn Hypothyroidism Musculoskeletal Diseases Thyroid Diseases

Age range

Up to 2 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levothyroxine

Drug

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

Ultrasound

Device

Primary outcomes

Dose Adjustments

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 number of dose adjustments required per participant during the first 6 months of treatment were recorded.

Secondary outcomes

Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls

Time frame: 6 months

Whether the dose adjustment was made for overtreatment was noted as based on TSH and fT4/T4 results

Sponsors and collaborators

Lead sponsor

Erica Eugster

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Mar 2, 2015
Registry last updated: Oct 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed