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Enrolling by Invitation

NCT Number: NCT07544290

Autoimmune Hyperthyroidism in Prepubertal Children

The investigators propose a multicenter retrospective study to assess clinical, biochemical, and auxological characteristics at diagnosis and during follow-up in a cohort of Caucasian pediatric patients diagnosed with autoimmune hyperthyroidism before puberty. These prepubertal patients will be compared with a control group of post-pubertal patients with Graves' disease.

This study aims to enhance the understanding of autoimmune hyperthyroidism in prepubertal patients by providing a detailed evaluation of disease onset, therapeutic response, and growth-related outcomes. The inclusion of a carefully matched post-pubertal control group will allow for robust comparative analysis and identification of age-dependent clinical patterns and prognostic indicators, ultimately supporting more tailored and effective management strategies in pediatric populations at this particular age.

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Key information

Conditions

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

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, Italy, 20132

About this study

There are only few studies in literature focusing on the analysis of cohorts of patients with autoimmune hyperthyroidism with onset exclusively in early childhood. The investigators therefore propose this study with the aim of retrospectively assessing characteristics at onset and during follow-up in a cohort of Caucasian hyperthyroid subjects diagnosed with the disease before puberty.

OBJECTIVES AND ENDPOINTS

  • Primary Objective To evaluate the clinical and biochemical features at the onset of autoimmune hyperthyroidism in patients diagnosed in prepubertal age Secondary Objectives
  • To evaluate of biochemical parameters during medical therapy
  • To evaluate of auxological parameters at diagnosis and during follow-up
  • To compare the previous data with the clinical and biochemical features at diagnosis and during the follow-up in patients diagnosed with Graves during the pubertal age (> Tanner 2)

Inclusion criteria

1. Subjects with autoimmune hyperthyroidism 2. Prepubertal stage (Tanner 1) at diagnosis Exclusion Criteria 3. Subjects with hyperthyroidism not of autoimmune aetiology 4. Pubertal stage (>Tanner 2) at diagnosis

Sample size:

  • 50 hyperthyroid subjects diagnosed with the disease before puberty
  • 50 hyperthyroid subjects diagnosed with the disease during and post puberty

The data will then be analyzed using PRISM software. The principal investigator will verify the completeness, correctness, consistency and congruence of the reported data.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-Subjects with autoimmune hyperthyroidism

Exclusion criteria

  • Subjects with hyperthyroidism not of autoimmune aetiology

Treatment and study plan

restrospective observational study

Other

we collect clinical, hormonal and follow up data and compare data in prepubertal and pubertal patients affected by autoimmune hyperthyroidism

Primary outcomes

  1. Number of clinical signs of hyperthyroidism at diagnosis

    Time frame: Day 0 (retrospective assessment at diagnosis)

    Total number of clinical signs (including goiter, exophthalmos, and tachycardia) present at diagnosis, recorded as a count per patient.

  2. Number of clinical symptoms at diagnosis

    Time frame: Day 0

    Total number of symptoms per patient, categorized as none (0), mild (1-2), moderate (3-5), or severe (>5).

  3. Serum free triiodothyronine (FT3) levels at diagnosis

    Time frame: Day 0

    Measurement of serum FT3 (pmol/L) at diagnosis.

  4. Serum free thyroxine (FT4) levels at diagnosis

    Time frame: Day 0

    Measurement of serum FT4 (pmol/L) at diagnosis.

  5. Serum thyroid-stimulating hormone (TSH) levels at diagnosis

    Time frame: Day 0

    Measurement of serum TSH (mIU/L) at diagnosis.

  6. Serum TSH receptor antibody (TRAb) levels at diagnosis

    Time frame: Day 0

    Measurement of TRAb levels (IU/L) at diagnosis.

  7. Thyroid autoantibody positivity at diagnosis (TPOAb and TgAb)

    Time frame: Day 0

    Presence or absence of thyroid autoantibodies (TPOAb and TgAb), reported as positive/negative.

Secondary outcomes

  1. Duration of antithyroid drug therapy

    Time frame: Baseline (treatment initiation) to treatment discontinuation (up to 24 months)

    Time in months from initiation of antithyroid drug therapy to treatment discontinuation or switch to definitive therapy, whichever occurs first.

  2. Remission rate after antithyroid drug therapy

    Time frame: At 24 months after treatment initiation

    Proportion of patients achieving sustained normalization of thyroid function (TSH, FT3, FT4) for at least 12 months after discontinuation of therapy.

  3. Rate of definitive treatment (thyroidectomy or radioactive iodine therapy)

    Time frame: Baseline to 24 months

    Proportion of patients requiring definitive treatment, defined as thyroidectomy or radioactive iodine therapy.

  4. Serum TSH receptor antibody (TRAb) levels at time of the definitive treatment

    Time frame: At time of definitive treatment (up to 24 months)

    Measurement of serum TRAb levels (IU/L) at the time of transition to definitive therapy.

  5. Time to normalization of thyroid function

    Time frame: Baseline to normalization (up to 12 months)

    Time in weeks from initiation of antithyroid therapy to normalization of FT3, FT4, and TSH levels.

  6. Aauxological parameters at diagnosis and during follow-up

    Time frame: day 0, diagnosis; at 6 months; at 12 months

    delta target height

  7. Number of antithyroid drug discontinuation attempts

    Time frame: Baseline to 24 months

    Number of attempts to discontinue antithyroid therapy per patient, categorized as successful or unsuccessful based on biochemical remission.

  8. Annual growth velocity during follow-up

    Time frame: Baseline to 24 months

    Change in height per year (cm/year).

  9. Bone age during follow-up

    Time frame: At baseline, 12 months, and 24 months

    Bone age assessed using Greulich and Pyle method.

Sponsors and collaborators

Lead sponsor

IRCCS Ospedale San Raffaele

Other

Collaborators

  • Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
  • Azienda Ospedaliera Universitaria Integrata Verona
  • Azienda Ospedaliera Universitaria Policlinico "G. Martino"
  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
  • Azienda Ospedaliero-Universitaria di Parma
  • Buzzi Children's Hospital
  • Federico II University
  • Fondazione IRCCS San Gerardo dei Tintori
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • S. Anna Hospital
  • University of Campania Luigi Vanvitelli
  • University of Genova
  • Università di Torino, Torino

Registry information

Official study title

Autoimmune Hyperthyroidism in Prepubertal Children With Onset Before 6 Years of Age: Characteristics at Diagnosis and Follow-Up Trends.

Acronym: IPER6

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

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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