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

Hypothyroidism Clinical Trial

Official title:

Establishing Reference Intervals for Thyroid Stimulating Hormone in Children Under the Age of Two Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877665
• Other study ID #: 5255-Pat-ERC-18
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: May 2021
• Source: Aga Khan University Hospital, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

A prospective cross-sectional study was conducted at the Section of Chemical Pathology, Department of Pathology and Laboratory Medicine, AKUH Karachi Pakistan, from August 2018 to March 2019 after approval from The Aga Khan University Ethics Review Committee.

Healthy children from 1 to 24 months visiting the clinical lab for serum vitamin D testing were invited to participate in the study.

Their health status was determined by asking questions related to their medical medical history after informed consent from their parents/guardian. Children with 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 were excluded.

The RIs were established using the CLSI, C28-A3 guidelines, using a sample size of at least 120 specimens.

Serum TSH and FT4 were measured on ADVIA Centaur (Siemens Diagnostics, US), using chemiluminescence immunoassay.

The EP evaluator version 10 and SPSS version 21 were used for data analysis. Kolmogorov-Smirnov test assessed the normality of the data.

The RIs based on central 95% of the population were established. The median age of subjects, TSH and FT4 levels were calculated. For assessing differences in the male and female gender, Students' t' test was applied, taking p-value <0.050 as significant. Spearman's test computed the correlation between age, TSH and FT4 levels.

A total of 132 children were included in the study; one subject with confirmed congenital hypothyroidism (CH) was excluded from the study, shown in figure 1. The TSH and FT4 values of 131 subjects were included to establish the RIs. The median (IQR) age of the study subjects was 12 (11) months, and 78 (59.5%) were male.

Reference interval based on central 95% of the population for TSH is 0.73-4.94 µIU/mL and for FT4 is 0.81-1.51 ng/dL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

Inclusion Criteria:

• Healthy children from 1 to 24 months

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypothyroidism

Locations

Country	Name	City	State
Pakistan	The Aga Khan University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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