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

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Diagnostic
  • Masking: None (Open Label)
• Study Primary Completion Date: September 30, 2020

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.

Interventions

• Diagnostic Test: chest x-ray
  • First Chest X-ray in the first 6 hours of infants

Arms, Groups and Cohorts

• Active Comparator: Infants born to COVID-19 positive mothers
  • Infants, born to COVID-19 positive mothers, will be evaluated for cardiothymic index in their first chest X-ray.
• No Intervention: Infants born to COVID-19 negative mothers
  • Infants, born to COVID-19 negative mothers, will be evaluated for cardiothymic index in their first chest X-ray.

Clinical Trial Outcome Measures

Primary Measures

• 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.

Secondary Measures

• Immune profile
  • Time Frame: 6 months
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 7 Hours

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Kanuni Sultan Suleyman Training and Research Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Seda Yilmaz Semerci, Neonatologist – Kanuni Sultan Suleyman Training and Research Hospital
• Overall Contact(s)
  • Seda Yilmaz Semerci, +905337180683, sedayilmazsemerci@gmail.com