check_circleStudy Completed

Hypothyroidism

Bayer Identifier:
18614
ClinicalTrials.gov Identifier:
NCT02766283
EudraCT Number:
Not Available
EU CT Number:
Not Available
Observational Study on Hypothyroidism in young Children following Iodine Contrast Exposure

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

0 - 3 Years
  • - 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)
  • - 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.

Trial summary

Enrollment Goal
843
Trial Dates
June 2016 - August 2016
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Israel

Primary Outcome

  • Number of pediatric patients with detected hypothyroidism after iodinated contrast exposure in a routine clinical practice setting
    date_rangeTime Frame:
    Up to one year after ICM exposure (828 person years)
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Baseline characteristics (sex) of the cases with hypothyroidism and of the rest of the cohort
    date_rangeTime Frame:
    Up to one year after ICM exposure (828 person years)
    enhanced_encryption
    Safety Issue:
    No
  • Baseline characteristics (age) of the cases with hypothyroidism and of the rest of the cohort
    date_rangeTime Frame:
    At first examination
    enhanced_encryption
    Safety Issue:
    No
  • Baseline characteristics (weight) of the cases with hypothyroidism and of the rest of the cohort
    date_rangeTime Frame:
    Within a range of ±360 days of the first examination
    enhanced_encryption
    Safety Issue:
    No
  • Baseline characteristics (comorbidity) of the cases with hypothyroidism and of the rest of the cohort
    date_rangeTime Frame:
    Prior to first examination
    enhanced_encryption
    Safety Issue:
    No
  • Baseline characteristics (sum of examinations) in cases with an indication of hypothyroidism and cases without
    date_rangeTime Frame:
    Up to one year after ICM exposure (828 person years)
    enhanced_encryption
    Safety Issue:
    No
  • Baseline characteristics (type of 1st examination) in cases with an indication of hypothyroidism and cases without
    date_rangeTime Frame:
    Up to one year after ICM exposure (828 person years)
    enhanced_encryption
    Safety Issue:
    No
  • Baseline characteristics (type of 2nd examination) in cases with an indication of hypothyroidism and cases without
    date_rangeTime Frame:
    Up to one year after ICM exposure (828 person years)
    enhanced_encryption
    Safety Issue:
    No
  • Baseline characteristics (time between examinations) in cases with an indication of hypothyroidism and cases without
    date_rangeTime Frame:
    Up to one year after ICM exposure (828 person years)
    enhanced_encryption
    Safety Issue:
    No
  • Time-relation between iodine contrast exposure and diagnosis of hypothyroidism
    date_rangeTime Frame:
    Up to one year after ICM exposure (828 person years)
    enhanced_encryption
    Safety Issue:
    No
  • The duration of hypothyroidism episode in the “probable iodine induced” category
    Based on the information collected from the database, the probable longest duration of Hypothyroidism was ascertained for the cases below.
    date_rangeTime Frame:
    Up to one year after ICM exposure (828 person years)
    enhanced_encryption
    Safety Issue:
    No
  • The duration of hypothyroidism episode in the “probable iodine induced” category
    Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below.
    date_rangeTime Frame:
    Up to one year after ICM exposure (828 person years)
    enhanced_encryption
    Safety Issue:
    No

Trial design

Observational Study on Hypothyroidism in young Children following Iodine Contrast Exposure
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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