Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00497575

Acronym

CHRO1

Enrollment

Unknown

Registered

2007-07-06

Start date

1999-10-31

Completion date

2006-09-30

Last updated

2007-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Hypothyroidism, Follow-Up, L-Thyroxine

Keywords

Congenital Hypothyroidism, diagnosis, L-thyroxine, newborn screening

Brief summary

Detailed description

Long term follow-up of the patients with delayed TSH elevation or subclinical hypothyroidism has been seldom reported. The purpose of this study was to explore the diagnostic criteria for subclinical hypothyroidism and the initial dosage of L-thyroxine through long-term follow up for infants with hyperthyrotropinemia，and evaluate the curative effect.All live-born neonates in province took part in the screening program from October, 1999 to September ,2006. Laboratory tests are performed as a time resolved fluoro-immunoassay (TRFIA). TSH is measured with a cut-off \> 9 mU/L. The diagnostic standard for subclinical hypothyroidism was: TSH ≥ 20 mU/L, T3 and T4 normal or low-normal ,or TSH \> 5.6 mU/L and \< 20 mU/L on initial determination and on follow-up or TSH levels increase on follow-up and/or gradually declining T4 levels.L-Thyroxine was administered for substitution therapy. After 2 years therapy，allround evaluation was performed. Compare the correlation to effects with different level of TSH、starting time of therapy and environment. Compare the effects between subclinical、temporary and permanent hypothyroidism.

Interventions

None listed

Study design

Observational model

DEFINED_POPULATION

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 5 Years

Inclusion criteria

* The diagnostic standard for manifest hypothyroidism and subclinical hypothyroidism was defined as follows: * Hypothyroidism - TSH \> 40 mU/L and T3 and T4 below the reference range or TSH \> 40 mU/L, T3 normal and T4 below the reference range \[2\] * Subclinical hypothyroidism - TSH ≥ 20 mU/L, T3 and T4 normal or low-normal or TSH \> 5.6 mU/L and \< 20 mU/L on initial determination and on follow-up or TSH levels increase on follow-up and/or gradually declining T4 levels.

Outcome results