Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?

Study Overview
=================
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.

Official Title
-----------------
Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?

Conditions
-----------------
Covid19, Thymic Hypoplasia

Intervention / Treatment
-----------------
* Diagnostic Test: chest x-ray


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 7 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infants born to COVID-19 positive mothers<br>Infants, born to COVID-19 positive mothers, will be evaluated for cardiothymic index in their first chest X-ray. | Diagnostic Test: chest x-ray<br>* First Chest X-ray in the first 6 hours of infants<br>|
| No Intervention: Infants born to COVID-19 negative mothers<br>Infants, born to COVID-19 negative mothers, will be evaluated for cardiothymic index in their first chest X-ray. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months |