Clinical Trials Logo
NCT number NCT03496363
Study type Observational
Source Assiut University
Contact Nagwa Ali Mohamed, Professor
Phone 01096260950
Email Nagwa.Abdelaal@med.au.edu.eg
Status Not yet recruiting
Phase
Start date May 1, 2018
Completion date May 1, 2020

Clinical Trial Summary

Congenital hypothyroidism is one of the most preventable causes of neurocognitive impairment because early treatment is possible in neonates. The thyroid hormone is important for normal growth and development in infancy. After introducing national screening test using capillary thyroid stimulating hormone level, the incidence of untreated congenital hypothyroidism has significantly decreased.

According to the Italian Registry of Congenital Hypothyroidism, congenital heart disease is the most frequent disease condition associated with congenital hypothyroidism.

Congenital heart disease is also reported to be a risk factor for non-autoimmune hypothyroidism in children. In addition, intravenous iodine contrast media is frequently used for diagnostic imaging and therapeutic intervention in congenital heart disease patients. Excess iodine exposed by iodine contrast media may disturb thyroid function in adult and pediatric population. However, there is no generally accepted guideline for screening thyroid dysfunction in congenital heart disease infants.

An increased prevalence of thyroid disease, particularly sub-clinical hypothyroidism, has been reported in Down Syndrome. In children with Down Syndrome, a possible concomitant sub-clinical hypothyroidism-related impairment of cardiac function or structure may worsen their clinical condition and can ultimately affect their life expectancy.


Clinical Trial Description

Aim of the work :

The aim of the work is to assess the thyroid function in children with congenital heart disease.

Inclusion criteria :

Patients with congenital heart diseases from birth (full term) to 3 years.

Exclusion criteria :

Patients with cardiac disease other than congenital heart disease. Preterm infants. Patients with other non cardiac congenital anomalies. Other endocrinal or central nervous system dysfunction. Maternal history of thyroid disease or antithyroid management.

Methods :

The study will be conducted in the Cardiology or Neonatology Units , Children's University Hospital, Faculty of Medicine, Assiut University on 50 patients both males and females.

All children will be evaluated by thoroughly history taken. Full general (including the anthropometric measures) and cardiac examinations will be done.

The patients will be conducted to investigations as:

Thyroid function tests. Electrocardiograph. X-ray chest and heart. Echocardiography.

Ethical considerations:

1. Risk benefit assessment, All patients will not be subjected to risk of any kind during this study.

2. Confidentiality, All patient's data will be confidential and stored in a secure location.

3. Informed consent, An informed consent will be taken from all patients and included.

4. Other ethical consideration, The research will be conducted only by scientifically qualified and trained personnel


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT01707056 - The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma N/A
Completed NCT00094237 - Subclinical Thyroid Dysfunction and Risk of Myocardial Infarction and Stroke N/A
Recruiting NCT02577367 - Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding Phase 4
Completed NCT01921452 - Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit Phase 4
Completed NCT01197183 - Observational Study With Prospective and/or Retrospective Follow-up, Without Modifying Patient Treatment and Follow-up Practices for the Initial Treatment of Hypothyroidism in France N/A
Completed NCT02959827 - Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States N/A
Not yet recruiting NCT03257566 - Hypothyroidism in Patients With Type 1 Diabetes N/A
Recruiting NCT02567877 - Is Levothyroxine Alone Adequate Thyroid Hormone Replacement?
Completed NCT02280330 - Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months Phase 4
Completed NCT00403390 - Generic vs. Name-Brand Levothyroxine N/A
Active, not recruiting NCT00287144 - Post Partum Thyroiditis 2: Long Term Observations Phase 4
Recruiting NCT02917863 - Randomized Crossover Trial for the Evaluation of the Possible Effects in the Intestine of Two Different Pharmaceutical Forms of L - Thyroxine in Patients With Primary Acquired Hypothyroidism Phase 4
Recruiting NCT02317926 - Desiccated Thyroid Extract Versus Synthetic T3/T4 Combination (ThyrolarTM) Versus L-T4 Alone in the Therapy of Primary Hypothyroidism With Special Attention to the Gene Polymorphism N/A
Active, not recruiting NCT02891668 - Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition N/A
Recruiting NCT01358136 - ThyrOp: A Study of Individual Subclinical Hypothyroidism After Hemithyroidectomy for Benign Nontoxic Goiter N/A
Active, not recruiting NCT01105923 - Study of an Intervention to Improve Problem List Accuracy and Use N/A
Completed NCT01050465 - MedlinePlus Health Prescriptions: Developing a Pragmatic Approach for Clinic Use N/A
Completed NCT00206375 - Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism Phase 4
Completed NCT02094079 - Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women With Hypothyroidism N/A
Completed NCT01800617 - A Study of T3 Therapy in Patients With Hypothyroidism Phase 2