Covid19NCT04470739
Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?
A study testing chest x-ray in people with Covid19 and Thymic Hypoplasia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. Investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal COVID-19. Read more about this study
- Who is it for?
- Ages Up to 7 hoursHealthy volunteers can take part
- Conditions the study is for
- Covid19, Thymic Hypoplasia
- What is being tested?
- chest x-ray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2020to 30 Oct 2020
- Phase
- Interventional
- 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 Up to 7 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born to COVID-19 positive or negative mothers
- Accepted to participate with an informed consent
- Infants who required to get chest X-ray within the first 6 hours
Who cannot join
- Infants whose mothers' have any kind of acute or chronic systemic disease or inflammation/infection
- Lack of an informed consent
- Infants who did not require to get chest X-ray within the first 6 hours
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34303
Seda Yilmaz Semerci, +905337180683, sedayilmazsemerci@gmail.com
About this study
COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. Investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and to demonstrate any possible association of this measurement with neonatal morbidities.
Read the detailed description
COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. Fetus is known to be influenced by maternal systemic infections. Thymus size of fetus and the neonate, is proven to be changed by primarily inflammatory/infectious diseases. Investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and to demonstrate any possible association of this measurement with neonatal morbidities.
- Conditions
- Covid19, Thymic Hypoplasia
- Being tested
- chest x-ray
- Medical subject headings
- COVID-19, DiGeorge Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest x-rayDiagnostic test
First Chest X-ray in the first 6 hours of infants
| Study group | Role | What they receive |
|---|---|---|
| Infants born to COVID-19 positive mothers | Active comparator | Infants, born to COVID-19 positive mothers, will be evaluated for cardiothymic index in their first chest X-ray. Receives: Diagnostic Test: chest x-ray |
| Infants born to COVID-19 negative mothers | No intervention | Infants, born to COVID-19 negative mothers, will be evaluated for cardiothymic index in their first chest X-ray. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiothymic index
Cardiothymic index will be measured by using the thymic shadow divided by largest diameter of mediastinum in the chest X-ray of those infants.
Measured: 4 months
Secondary outcomes (1)
Immune profile
In long term follow up of those patients, infants will be evaluated for any kind of immune deficiency or quantitative or qualitative abnormalities of leukocytes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start30 May 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470739
- Sponsor's protocol ID
- KSSEAH--CT
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?
- ClinicalTrials.gov ID
- NCT04470739
- Acronym / sponsor ID
- KSSEAH--CT
- Conditions
- Covid19, Thymic Hypoplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 30 May 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 14 Jul 2020 (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.
COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. Investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and to demonstrate any possible association of this measurement with neonatal morbidities.
Detailed description
COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. Fetus is known to be influenced by maternal systemic infections. Thymus size of fetus and the neonate, is proven to be changed by primarily inflammatory/infectious diseases. Investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and to demonstrate any possible association of this measurement with neonatal morbidities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants born to COVID-19 positive mothers | Active comparator | Diagnostic Test: chest x-rayInfants, born to COVID-19 positive mothers, will be evaluated for cardiothymic index in their first chest X-ray. |
| Infants born to COVID-19 negative mothers | No intervention | –Infants, born to COVID-19 negative mothers, will be evaluated for cardiothymic index in their first chest X-ray. |
Who may qualify
- Ages
- Up to 7 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants born to COVID-19 positive or negative mothers
- Accepted to participate with an informed consent
- Infants who required to get chest X-ray within the first 6 hours
Key exclusion criteria (3 listed)
- Infants whose mothers' have any kind of acute or chronic systemic disease or inflammation/infection
- Lack of an informed consent
- Infants who did not require to get chest X-ray within the first 6 hours
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 |
|---|---|---|
| chest x-rayFirst Chest X-ray in the first 6 hours of infants | Diagnostic test | Infants born to COVID-19 positive mothers |
Primary outcome
Cardiothymic index
Time frame: 4 months
Cardiothymic index will be measured by using the thymic shadow divided by largest diameter of mediastinum in the chest X-ray of those infants.
1 secondary outcome
Immune profile
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chest x-ray in people with Covid19 and Thymic Hypoplasia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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: status not confirmed, as of the sponsor's last update on 14 Jul 2020. 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 Turkey (Türkiye). 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 Seda Yilmaz Semerci (+905337180683, sedayilmazsemerci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiothymic index (time frame: 4 months). 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 14 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.