N/A
N=68
Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism
Congenital Hypothyroidism
Bottom Line
View on ClinicalTrials.gov: NCT02374593 ↗Enrolled (actual)
68
Serious AEs
—
Results posted
Oct 2017
Primary outcome: Primary: Dose Adjustments — 2.5; 2.4 Number of dose adjustments
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Levothyroxine (Drug); Ultrasound (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Erica Eugster
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Adjustments |
2.5; 2.4 | — |
| SECONDARY Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls |
2.7; 2; 1; 2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02374593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.