N/A
N=843
Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure
Hypothyroidism
Bottom Line
View on ClinicalTrials.gov: NCT02766283 ↗Enrolled (actual)
843
Serious AEs
—
Results posted
Mar 2018
Primary outcome: Primary: Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting — 11 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- iodinated contrast agents (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting |
11 | — |
| SECONDARY Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort |
454; 7; 378; 4 | — |
| SECONDARY Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort |
1.07; 0.53 | — |
| SECONDARY Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort |
8.84; 6.57 | — |
| SECONDARY Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort |
485; 10; 1; 0; 21; 0 | — |
| SECONDARY Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without |
765; 10; 67; 1 | 0.90 |
| SECONDARY Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without |
471; 10; 361; 1 | 0.022 sig |
| SECONDARY Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without |
46; 1; 21; 0 | — |
| SECONDARY Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without |
282.72; 288; 208.19; 212.00 | — |
| SECONDARY Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism |
76.54 | — |
| SECONDARY The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category |
14; 8 | — |
| SECONDARY The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category |
14; 8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02766283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.