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

Not Applicable

• Conditions: Covid19; Thymic Hypoplasia
• Interventions: Diagnostic Test: chest x-ray

• Registration Number: NCT04470739
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Study Timeline

• Study Start: 2020-05-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-12
• Study First Submitted QC: 2020-07-13
• Last Update Submitted: 2020-07-13
• Study First Posted: 2020-07-14
• Last Update Posted: 2020-07-14
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infants born to COVID-19 positive mothers	chest x-ray	Infants, born to COVID-19 positive mothers, will be evaluated for cardiothymic index in their first chest X-ray.

Primary Outcome Measures

Name	Time	Method
Cardiothymic index	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 Outcome Measures

Name	Time	Method
Immune profile	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

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey