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Completed

NCT Number: NCT02766283

Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure

To investigate the incidence of detected hypothyroidism after iodinated contrast exposure in pediatric patients from birth to 3 years of age (inclusive) in a routine clinical practice setting.

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All children age 0-3 years (inclusive) who are identified of having undergone a radiological examination with intravascular use of an iodinated contrast agent.(e.g.

contrast enhanced CT, cardioangiography)

Exclusion criteria

  • Congenital Hypothyroidism or other forms of preexisting hypothyroidism
  • Preexisting thyroid hormone replacement therapy less than three months of observation before the radiological examination (if greater than three months old)
  • Less than two weeks follow-up available after the contrast exposure.

Treatment and study plan

iodinated contrast agents

Drug

Intravascular application

Primary outcomes

  1. Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting

    Time frame: Up to one year after iodinated contrast material (ICM) exposure (828 person years)

Secondary outcomes

  1. Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort

    Time frame: Up to one year after ICM exposure (828 person years)

  2. Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort

    Time frame: At first examination

  3. Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort

    Time frame: Within a range of ±360 days of the first examination

  4. Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort

    Time frame: Prior to first examination

  5. Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without

    Time frame: Up to one year after ICM exposure (828 person years)

  6. Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without

    Time frame: Up to one year after ICM exposure (828 person years)

  7. Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without

    Time frame: Up to one year after ICM exposure (828 person years)

  8. Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without

    Time frame: Up to one year after ICM exposure (828 person years)

  9. Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism

    Time frame: Up to one year after ICM exposure (828 person years)

  10. The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category

    Time frame: Up to one year after ICM exposure (828 person years)

    Based on the information collected from the database, the probable longest duration of Hypothyroidism was ascertained for the cases below.

  11. The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category

    Time frame: Up to one year after ICM exposure (828 person years)

    Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 9, 2016
Registry last updated
Mar 26, 2018

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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