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

NCT ID: NCT04470739

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-30

Study Completion Date

2020-10-30

Brief Summary

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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

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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.

Conditions

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Covid19 Thymic Hypoplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

chest x-ray

Intervention Type DIAGNOSTIC_TEST

First Chest X-ray in the first 6 hours of infants

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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chest x-ray

First Chest X-ray in the first 6 hours of infants

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

7 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seda Yilmaz Semerci

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Seda Yilmaz Semerci

Role: CONTACT

+905337180683

Facility Contacts

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Seda Yilmaz Semerci

Role: primary

+905337180683

Other Identifiers

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KSSEAH--CT

Identifier Type: -

Identifier Source: org_study_id

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