Thyroid Functions in Children With Congenital Heart Diseases

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05103774
Collaborator
(none)
100
1
11.5
8.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: T3-T4-TSH

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Thyroid Functions in Children With Congenital Heart Diseases
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Group A: children exposed to any type of radiation or contrast

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

Group B : children not exposed to an type of radiation or contrast

Diagnostic Test: T3-T4-TSH
thyroid function tests

Outcome Measures

Primary Outcome Measures

  1. Assessment of thyroid function in children with congenital heart diseases at Sohag University hospital [One year]

    Thyroid function tests will be obtained from children with congenital heart diseases as will as the control group

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital of Sohag University Sohag Egypt 82524

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hend Abdelrahim Saber, Resident doctor at Pediatric department Sohag University hospital, Sohag University
ClinicalTrials.gov Identifier:
NCT05103774
Other Study ID Numbers:
  • Soh Med-21-10-24
First Posted:
Nov 2, 2021
Last Update Posted:
Nov 2, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2021