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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04470739
• Other study ID #: KSSEAH--CT
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: July 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: Seda Yilmaz Semerci
• Phone: +905337180683
• Email: sedayilmazsemerci[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Hours

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• DiGeorge Syndrome
• Thymic Hypoplasia

Intervention

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

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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