Value of Thyroid Functions in Children With Congenital Heart DiseasesNCT05103774
Thyroid Functions in Children With Congenital Heart Diseases
An observational study of Value of Thyroid Functions in Children With Congenital Heart Diseases, run by Sohag University at 1 site in Egypt.
Trial summary
Thyroid hormone is critical for normal neurocognitive development in young infants, and even transient hypothyroidism can cause adverse neurodevelopmental outcomes. In a population of infants with CHD who already bear a high risk of long-term developmental delay, detection of hypothyroidism, even of a transient… Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Value of Thyroid Functions in Children With Congenital Heart Diseases
- What is being tested?
- T3-T4-TSH
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 15 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: * Place of the study: Sohag University Hospital (pediatrics department -cardiology unit). * Sample size the whole sample size will be at least 100 child diagnosed as CHD divided equally into two groups (group A and B) Group A: children exposed to any type of radiation or contrast Group B : children not exposed to an type of radiation or contrast
Who may be able to join
- All children since birth up to age of 12 years old including both genders diagnosed to have CHD exposed to radiation, contrast or not.
Who cannot join
- above 12 years old
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Hospital of Sohag University
Sohag, 82524
hend raheem saber, master, 01017590751, hend011221@med.sohag.edu.eg
Eman Mohamed Fahmy, md, 01061277030, hend011221@med.sohag.edu.eg
About this study
Thyroid hormone is critical for normal neurocognitive development in young infants, and even transient hypothyroidism can cause adverse neurodevelopmental outcomes. In a population of infants with CHD who already bear a high risk of long-term developmental delay, detection of hypothyroidism, even of a transient nature, may be even more consequential, and routine periodic monitoring of thyroid function may be necessary to reduce the risk of neurodevelopmental disabilities
- Being tested
- T3-T4-TSH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3-T4-TSHDiagnostic test
thyroid function tests
| Study group | Role | What they receive |
|---|---|---|
| Group A: children exposed to any type of radiation or contrast | Group A: children exposed to any type of radiation or contrast Receives: Diagnostic Test: T3-T4-TSH | |
| Group B : children not exposed to an type of radiation or contrast | Group B : children not exposed to an type of radiation or contrast Receives: Diagnostic Test: T3-T4-TSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of thyroid function in children with congenital heart diseases at Sohag University hospital
Thyroid function tests will be obtained from children with congenital heart diseases as will as the control group
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Value of Thyroid Functions in Children With Congenital Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Abdelrahim Saber, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103774
- Sponsor's protocol ID
- Soh Med-21-10-24
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Functions in Children With Congenital Heart Diseases
- ClinicalTrials.gov ID
- NCT05103774
- Acronym / sponsor ID
- Soh Med-21-10-24
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thyroid hormone is critical for normal neurocognitive development in young infants, and even transient hypothyroidism can cause adverse neurodevelopmental outcomes. In a population of infants with CHD who already bear a high risk of long-term developmental delay, detection of hypothyroidism, even of a transient nature, may be even more consequential, and routine periodic monitoring of thyroid function may be necessary to reduce the risk of neurodevelopmental disabilities
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: children exposed to any type of radiation or contrast | – | Diagnostic Test: T3-T4-TSHGroup A: children exposed to any type of radiation or contrast |
| Group B : children not exposed to an type of radiation or contrast | – | Diagnostic Test: T3-T4-TSHGroup B : children not exposed to an type of radiation or contrast |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * Place of the study: Sohag University Hospital (pediatrics department -cardiology unit). * Sample size the whole sample size will be at least 100 child diagnosed as CHD divided equally into two groups (group A and B) Group A: children exposed to any type of radiation or contrast Group B : children not exposed to an type of radiation or contrast
Key inclusion criteria (1 listed)
- All children since birth up to age of 12 years old including both genders diagnosed to have CHD exposed to radiation, contrast or not.
Key exclusion criteria (1 listed)
- above 12 years old
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 |
|---|---|---|
| T3-T4-TSHthyroid function tests | Diagnostic test | Group A: children exposed to any type of radiation or contrast, Group B : children not exposed to an type of radiation or contrast |
Primary outcome
Assessment of thyroid function in children with congenital heart diseases at Sohag University hospital
Time frame: One year
Thyroid function tests will be obtained from children with congenital heart diseases as will as the control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Individual participant dataSharing planned: Undecided
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.
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 Value of Thyroid Functions in Children With Congenital Heart Diseases, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Nov 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hend raheem saber, master (01017590751, hend011221@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of thyroid function in children with congenital heart diseases at Sohag University hospital (time frame: One year). 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 2 Nov 2021.