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

NCT06357494 | Not Yet Recruiting

• 1 other identifier: Thyroid Doppler in Graves'
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Graves' Disease

Outcome Measures

Primary Outcomes (5)

• 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

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Graves Disease

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Hanaa A Mohamad, Professor of pediatrics

CONTACT

01064747613; hae50@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of pediatrics

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): April 5, 2027
• Study Completion (Estimated): April 5, 2028
• Last Updated: July 16, 2024

Record last verified: 2024-07