Assessment of Thyroid Doppler Ultrasound in Followup of Pediatric Graves' Disease

All cases of the study will be diagnosed as Graves' by History, examination, laboratory (FT3, FT4, TSH & TRAbs), X-ray on left wrist for bone age, neck grey scale ultrasonography for thyroid gland size, shape, echotexture, vascularity and nodule characters if present with TIRAD score calculation.

Then Color flow doppler ultrasound will be done to asses thyroid volume, number of vessels per square cm and inferior thyroid artery peak systolic velocity, end diastolic velocity and resistive index. Patients then will receive carbimazole antithyroid drug at dose 0.25-0.5 mg/kg/day PO & the dose will be titrated according to thyroid function test after 4-6 weeks.

Beta-adrenergic blockade will be added to all symptomatic cases. Regular follow up will be done every month of first 3 months of diagnosis and then every 3 months for 2 years by clinical and thyroid function test to asses response, compliance, complications, drug side effects, remission and relapses.

Doppler ultrasound will be done at 0, 12 and 24 months.

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Key information

Conditions

Graves' Disease Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Graves Disease Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All newly diagnosed children with clinical and laboratory hyperthyroidism (high T4 & low TSH) with positive TRAbs.

Exclusion criteria

Patients receiving radioiodine Patients underwent thyroid surgery History of neck radiation or neck surgery

Treatment and study plan

Primary outcomes

thyroid volume

Time frame: 3 years
number of vessels per square cm of thyroid gland

Time frame: 2 years
inferior thyroid artery peak systolic velocity

Time frame: 2 years
end diastolic velocity

Time frame: 2 years
resistive index

Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Hanaa A Mohamad, Professor of pediatrics

CONTACT

[email protected]

01064747613

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Assessment of Thyroid Doppler Ultrasound in Relation to Clinical and Laboratory Parameters in Follow up of Pediatric Graves' Disease

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2028
First posted: Apr 10, 2024
Registry last updated: Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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