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Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

NCT ID: NCT02374593

Last Updated: 2017-10-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Hypothyroidism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Levothyroxine

Intervention Type DRUG

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

Ultrasound

Intervention Type DEVICE

Interventions

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Levothyroxine

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

Intervention Type DRUG

Ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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.
Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erica Eugster

OTHER

Sponsor Role lead

Responsible Party

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Erica Eugster

Pediatric Endocrinologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Erica Eugster, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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1401199401

Identifier Type: -

Identifier Source: org_study_id