Establishing RIs for TSH in Children Under the Age of Two Years

NCT04877665 | Completed

• 1 other identifier: 5255-Pat-ERC-18
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

Reference intervals (RIs) of thyroid-stimulating hormone (TSH) and free thyroxine (FT4) are age, assay and population specific. Currently, the age and assay-specific RIs for TSH are not available for children under two years of age. This study aimed to establish reference intervals for serum concentrations of TSH and FT4 in healthy children aged 1-24 months as per CLSI C28-A3 guidelines.

Conditions

Hypothyroidism

Keywords

Thyroid Stimulating Hormone; Reference Interval; Children; Pakistan

Outcome Measures

Primary Outcomes (1)

• Establishing Reference Intervals for Thyroid Stimulating Hormone in Children under the age of two years

  This study aimed to establish reference intervals for serum concentrations of TSH and FT4 in healthy children aged 1-24 months as per CLSI C28-A3 guidelines.

  August 2018 to March 2019

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy children from 1 to 24 months

You may qualify if:

• Healthy children from 1 to 24 months

You may not qualify if:

• recent illness, hospitalization, medication and maternal history of thyroid-related diseases, recent abnormal total leucocyte or neutrophil count in the medical record or positive microbial cultures, history of any diagnosed disease or infection, history of hospitalization during the previous four weeks, congenital hypothyroidism or transient congenital hypothyroidism, history of maternal thyroid illness, or any medications with potential influences on the thyroid function, such as amiodarone, anti-epileptic drugs, glucocorticoids

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (1)

The Aga Khan University

Karachi, Sindh, 3500, Pakistan

Location

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• Siraj Muneer

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 7, 2021
• Study Start: August 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

PA (1)