Study 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

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.

Trial summary

Enrollment Goal

843

Trial Dates

June 2016 - August 2016

Phase

N/A

Could I Receive a placebo

Products

Unspecified

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Israel

Primary Outcome

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

Secondary Outcome

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)
Safety Issue:
No
Baseline characteristics (age) of the cases with hypothyroidism and of the rest of the cohort
Time Frame:
At first examination
Safety Issue:
No
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
Safety Issue:
No
Baseline characteristics (comorbidity) of the cases with hypothyroidism and of the rest of the cohort
Time Frame:
Prior to first examination
Safety Issue:
No
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)
Safety Issue:
No
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)
Safety Issue:
No
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)
Safety Issue:
No
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)
Safety Issue:
No
Time-relation between iodine contrast exposure and diagnosis of hypothyroidism
Time Frame:
Up to one year after ICM exposure (828 person years)
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.
Time Frame:
Up to one year after ICM exposure (828 person years)
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.
Time Frame:
Up to one year after ICM exposure (828 person years)
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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