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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted dosing | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine | Drug | Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erica Eugster, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Targeted Dosing | 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. |
| FG001 | Historical Control | Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Targeted Dosing | 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. |
| BG001 | Historical Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | Number of dose adjustments | 6 months |
|
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Adverse events were not monitored as all subjects were treated according to existing clinical standards of care
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Targeted Dosing | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erica Eugster | Riley Hospital for Children | 317 944-3889 | eeugster@iu.edu |
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| ID | Term |
|---|---|
| D003409 | Congenital Hypothyroidism |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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| Ultrasound | Device |
|
Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day. |
| BG002 | Total | Total of all reporting groups |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Posted | Mean | Standard Error | dose adjustments | 6 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Historical Control | Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day. | 0 | 0 | 0 | 0 |
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| D001849 |
| Bone Diseases, Endocrine |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D007037 | Hypothyroidism |
| D013959 | Thyroid Diseases |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |