Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02766283
NCT02766283CompletedNot Applicable

Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure

Bayer0 sites843 target enrollmentStarted: June 30, 2016Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Bayer
Enrollment
843
Primary Endpoint
Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
— to 3 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Iodinated contrast agents

children age 0-3 years (inclusive), who underwent a iodine contrast enhanced radiological examination.

Intervention: iodinated contrast agents (Drug)

Outcomes

Primary Outcomes

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

  • Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort(Up to one year after ICM exposure (828 person years))
  • Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort(Within a range of ±360 days of the first examination)
  • Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort(At first examination)
  • Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort(Prior to first examination)
  • Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism(Up to one year after ICM exposure (828 person years))
  • Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without(Up to one year after ICM exposure (828 person years))
  • Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without(Up to one year after ICM exposure (828 person years))
  • Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without(Up to one year after ICM exposure (828 person years))
  • Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without(Up to one year after ICM exposure (828 person years))
  • The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category(Up to one year after ICM exposure (828 person years))

Investigators

Sponsor
Bayer
Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials

Completed
Not Applicable
Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United StatesHypothyroidism
NCT02959827Bayer2,320
Unknown
Not Applicable
Measurement of Hormonal Concentration in Chylothorax Fluid in Infants With Congenital ChylothoraxCongenital Chylothorax
NCT00267345Sheba Medical Center15
Completed
Not Applicable
Screening for congenital hypothyroidism using umbilical cord blood TSH
CTRI/2014/05/004618DR MARIO JOSEPH BUKELO4,500
Completed
Not Applicable
Thyroid Function in Term Infants With Respiratory DistressTransient HypothyroxinemiaInfant, Newborn
NCT00293956Christiana Care Health Services20
Recruiting
Not Applicable
Jodkids: a Study of Iodine Intake Among Children Aged 2-10 YearsDiet HabitIodine DeficiencyIodine Toxicity
NCT06234982DTU National Food Institute600