Thyroid Functions in Children With Congenital Heart Diseases

October 31, 2021 updated by: Hend Abdelrahim Saber, Sohag University
Thyroid hormone is critical for normal neurocognitive development in young infants, and even transient hypothyroidism can cause adverse neurodevelopmental outcomes. In a population of infants with CHD who already bear a high risk of long-term developmental delay, detection of hypothyroidism, even of a transient nature, may be even more consequential, and routine periodic monitoring of thyroid function may be necessary to reduce the risk of neurodevelopmental disabilities

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • Place of the study: Sohag University Hospital (pediatrics department -cardiology unit).
  • Sample size the whole sample size will be at least 100 child diagnosed as CHD divided equally into two groups (group A and B) Group A: children exposed to any type of radiation or contrast Group B : children not exposed to an type of radiation or contrast

Description

Inclusion Criteria:

  • All children since birth up to age of 12 years old including both genders diagnosed to have CHD exposed to radiation, contrast or not.

Exclusion Criteria:

  • above 12 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A: children exposed to any type of radiation or contrast
Diagnostic test: T3-T4-TSH
thyroid function tests
Group B : children not exposed to an type of radiation or contrast
Diagnostic test: T3-T4-TSH
thyroid function tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of thyroid function in children with congenital heart diseases at Sohag University hospital
Time Frame: One year
Thyroid function tests will be obtained from children with congenital heart diseases as will as the control group
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2021

Primary Completion (ANTICIPATED)

November 1, 2022

Study Completion (ANTICIPATED)

November 15, 2022

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 31, 2021

First Posted (ACTUAL)

November 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 31, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh Med-21-10-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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