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Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

Primary Purpose

Congenital Hypothyroidism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Levothyroxine
Ultrasound
Sponsored by
Erica Eugster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Hypothyroidism

Eligibility Criteria

undefined - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Riley Hospital for Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Targeted dosing

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2015
Last Updated
October 6, 2017
Sponsor
Erica Eugster
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1. Study Identification

Unique Protocol Identification Number
NCT02374593
Brief Title
Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism
Official Title
Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erica Eugster

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Hypothyroidism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeted dosing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Intervention Description
Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Primary Outcome Measure Information:
Title
Dose Adjustments
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls
Description
Whether the dose adjustment was made for overtreatment was noted as based on TSH and fT4/T4 results
Time Frame
6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica Eugster, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

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