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

April 5, 2024 updated by: A.L.Mohamed, Assiut University

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

Study Type

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To make follow up of graves disease easier and improve patients adherence to treatment and follow up plan.
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 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)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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