Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

NCT02374593 | Completed Results DMC

• 1 other identifier: 1401199401
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Hypothyroidism

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls

  6 months

Study Arms (1)

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.

Drug: Levothyroxine; Device: Ultrasound

Interventions

Levothyroxine DRUG

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

Targeted dosing

Ultrasound DEVICE

Targeted dosing

Eligibility Criteria

• Age: Up to 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Newborns who do not have CH.
• Newborns with CH who have not had thyroid imaging performed at diagnosis.

Sponsors & Collaborators

• Erica Eugster: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Congenital Hypothyroidism

Interventions

Thyroxine; Ultrasonography

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Hypothyroidism; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Erica Eugster
• Organization: Riley Hospital for Children

eeugster@iu.edu

317 944-3889

Study Officials

• Erica Eugster, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric Endocrinologist

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 2, 2015
• Study Start: March 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 9, 2017
• Results First Posted: October 9, 2017

Record last verified: 2017-10

Locations

US (1)