Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure

NCT02766283 | Completed Results FDA Drug

• 1 other identifier: 18614
• Study Type: observational
• Target: 843
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothyroidism

Keywords

Children; Iodinated contrast agents

Outcome Measures

Primary Outcomes (1)

• Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting

  Up to one year after iodinated contrast material (ICM) exposure (828 person years)

Secondary Outcomes (11)

• 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 (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort

  At first examination

• 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 (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort

  Prior to first examination

• 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)

Study Arms (1)

Iodinated contrast agents

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

Drug: iodinated contrast agents

Interventions

iodinated contrast agents DRUG

Intravascular application

Iodinated contrast agents

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Members of Maccabi Health Services database (Israel)

You may qualify if:

• \- 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Israel

Location

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Limitations and Caveats

This study is a retrospective database analysis study. The safety outcome focused on the incidence of hypothyroidism for up to one year after iodine contrast exposure. Please refer to the result of primary outcome measure for safety evaluation.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

+49 30 300139003

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 9, 2016
• Study Start: June 30, 2016
• Primary Completion: August 30, 2016
• Study Completion: August 30, 2016
• Last Updated: March 26, 2018
• Results First Posted: March 26, 2018

Record last verified: 2018-03

Locations

IL (1)