Clinical trial NCT02766283: Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure
Official title: Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothyroidism
Keywords: Children
Iodinated contrast agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-05-09
Enrollment: 843
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of Maccabi Health Services database (Israel)

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting
timeFrame: Up to one year after iodinated contrast material (ICM) exposure (828 person years)
Secondary outcomes:
measure: Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort
timeFrame: Up to one year after ICM exposure (828 person years)
measure: Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort
timeFrame: At first examination
measure: Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort
timeFrame: Within a range of ±360 days of the first examination
measure: Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort
timeFrame: Prior to first examination
measure: Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without
timeFrame: Up to one year after ICM exposure (828 person years)
measure: Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without
timeFrame: Up to one year after ICM exposure (828 person years)
measure: Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without
timeFrame: Up to one year after ICM exposure (828 person years)
measure: Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without
timeFrame: Up to one year after ICM exposure (828 person years)
measure: Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism
timeFrame: Up to one year after ICM exposure (828 person years)
measure: The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category
timeFrame: Up to one year after ICM exposure (828 person years)
measure: The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category
timeFrame: Up to one year after ICM exposure (828 person years)
Other outcomes:
Locations:
city: Multiple Locations
country: Israel
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: