Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?
Primary Purpose
Covid19, Thymic Hypoplasia
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
chest x-ray
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Kanuni Sultan Suleyman Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Infants born to COVID-19 positive mothers
Infants born to COVID-19 negative mothers
Arm Description
Infants, 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, will be evaluated for cardiothymic index in their first chest X-ray.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04470739
First Posted
July 12, 2020
Last Updated
July 13, 2020
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04470739
Brief Title
Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?
Official Title
Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Thymic Hypoplasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infants born to COVID-19 positive mothers
Arm Type
Active Comparator
Arm Description
Infants, born to COVID-19 positive mothers, will be evaluated for cardiothymic index in their first chest X-ray.
Arm Title
Infants born to COVID-19 negative mothers
Arm Type
No Intervention
Arm Description
Infants, born to COVID-19 negative mothers, will be evaluated for cardiothymic index in their first chest X-ray.
Intervention Type
Diagnostic Test
Intervention Name(s)
chest x-ray
Intervention Description
First Chest X-ray in the first 6 hours of infants
Primary Outcome Measure Information:
Title
Cardiothymic index
Description
Cardiothymic index will be measured by using the thymic shadow divided by largest diameter of mediastinum in the chest X-ray of those infants.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Immune profile
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seda Yilmaz Semerci
Phone
+905337180683
Email
sedayilmazsemerci@gmail.com
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seda Yilmaz Semerci
Phone
+905337180683
Email
sedayilmazsemerci@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?
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