HypothyroidismNCT02766283
Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure
An observational study of Hypothyroidism, run by Bayer at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- iodinated contrast agents
- How many people
- 843 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jun 2016to 30 Aug 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Members of Maccabi Health Services database (Israel)
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- iodinated contrast agents
- Keywords
- Children, Iodinated contrast agents
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iodinated contrast agentsDrug
Intravascular application
| Study group | Role | What they receive |
|---|---|---|
| Iodinated contrast agents | children age 0-3 years (inclusive), who underwent a iodine contrast enhanced radiological examination. Receives: Drug: iodinated contrast agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting
Measured: 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
Measured: 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
Measured: At first examination
Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort
Measured: 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
Measured: Prior to first examination
Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without
Measured: 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
Measured: 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
Measured: 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
Measured: Up to one year after ICM exposure (828 person years)
Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism
Measured: Up to one year after ICM exposure (828 person years)
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.
Measured: Up to one year after ICM exposure (828 person years)
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.
Measured: Up to one year after ICM exposure (828 person years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study start30 Jun 2016
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766283
- Sponsor's protocol ID
- 18614
- Status last verified
- Mar 2018
- First submitted
- 6 May 2016
- Last updated
- 26 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure
- ClinicalTrials.gov ID
- NCT02766283
- Acronym / sponsor ID
- 18614
- Conditions
- Hypothyroidism
- Keywords
- Children, Iodinated contrast agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 9 May 2016 (estimated)
- Results
- Posted 26 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iodinated contrast agents | – | Drug: iodinated contrast agentschildren age 0-3 years (inclusive), who underwent a iodine contrast enhanced radiological examination. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Members of Maccabi Health Services database (Israel)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iodinated contrast agentsIntravascular application | Drug | Iodinated contrast agents |
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 iodinated contrast material (ICM) exposure (828 person years)
11 secondary outcomes
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)
Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort
Time frame: At first examination
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
Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort
Time frame: Prior to first examination
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)
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)
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)
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)
Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism
Time frame: Up to one year after ICM exposure (828 person years)
The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category
Time frame: Up to one year after ICM exposure (828 person years)
The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category
Time frame: Up to one year after ICM exposure (828 person years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Bayer at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.