Clinical trial NCT03496363: Hypothyroidism With Congenital Heart Disease (CHD)
Official title: Evaluation of Thyroid Function in Children With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypothyroidism
CHD
Keywords: Children
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with congenital heart disease

Brief 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.

Detailed 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

Eligibility criteria: 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 CNS dysfunction
* Maternal history of thyroid disease or antithyroid management

Primary outcomes:
measure: EVALUATE THYROID FUNCTION IN PATIENTS WITH CONGENITAL HEART DISEASE
timeFrame: May 2018 - May 2020
Secondary outcomes:
measure: Detect the percentage of patients with congenital heart disease and have no thyroid problems
timeFrame: May 2018 - May 2020
Other outcomes:
Locations:
Study officials:
References:
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