NCT00497575

Brief Summary

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 subclinical hypothyroidism ，and evaluate the curative effect.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 1999

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
Last Updated

July 6, 2007

Status Verified

July 1, 2007

First QC Date

July 5, 2007

Last Update Submit

July 5, 2007

Conditions

Congenital HypothyroidismL-ThyroxineFollow-Up

Keywords

Congenital HypothyroidismdiagnosisL-thyroxinenewborn screening

Eligibility Criteria

AgeUp to 5 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Congenital HypothyroidismDisease

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System DiseasesHypothyroidismThyroid DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • zhengyan Zhao, doctor

    Pediatric Society of the Chinese Medical Association

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 6, 2007

Study Start

October 1, 1999

Study Completion

September 1, 2006

Last Updated

July 6, 2007

Record last verified: 2007-07