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

Assessment of Thyroid Doppler Ultrasound in Relation to Clinical and Laboratory Parameters in Follow up 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Graves' Disease

• Study Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

• Study Contact: Name: Hanaa A Mohamad, Professor of pediatrics; Phone Number: 01064747613; Email: hae50@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

children who will come at pediatric endocrinology outpatient clinic of Assiut University Children's Hospital meeting our inclusion criteria.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
thyroid volume	3 years
number of vessels per square cm of thyroid gland	2 years
inferior thyroid artery peak systolic velocity	2 years
end diastolic velocity	2 years
resistive index	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
better control of disease in our patients, less complications, less mortality and better prognosis.	4 years

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): August 5, 2024
• Primary Completion (Estimated): April 5, 2027
• Study Completion (Estimated): April 5, 2028

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 14, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Endocrine System Diseases; Thyroid Diseases; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Graves Disease
• Other Study ID Numbers: Thyroid Doppler in Graves'

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No