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Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

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ClinicalTrials.gov Identifier: NCT02374593
Recruitment Status : Completed
First Posted : March 2, 2015
Results First Posted : October 9, 2017
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Erica Eugster, Indiana University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Congenital Hypothyroidism Drug: Levothyroxine Device: Ultrasound Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism
Study Start Date : March 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Levothyroxine
Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound.

Device: Ultrasound


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374593


Locations
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United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Erica Eugster
Investigators
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Principal Investigator: Erica Eugster, MD Indiana University
More Information
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Responsible Party: Erica Eugster, Pediatric Endocrinologist, Indiana University
ClinicalTrials.gov Identifier: NCT02374593    
Other Study ID Numbers: 1401199401
First Posted: March 2, 2015    Key Record Dates
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Congenital Hypothyroidism
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Dwarfism
 Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Genetic Diseases, Inborn