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

July 13, 2020 updated by: Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34303
        • Recruiting
        • Kanuni Sultan Suleyman Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Diagnostic test: chest x-ray
First Chest X-ray in the first 6 hours of infants
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2020

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

October 30, 2020

Study Registration Dates

First Submitted

July 12, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSSEAH--CT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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