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

NCT04470739 | Unknown

• 1 other identifier: KSSEAH--CT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Thymic Hypoplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immune profile

  6 months

Study Arms (2)

Infants born to COVID-19 positive mothers

ACTIVE COMPARATOR

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

Diagnostic Test: chest x-ray

Infants born to COVID-19 negative mothers

NO INTERVENTION

Infants, born to COVID-19 negative mothers, will be evaluated for cardiothymic index in their first chest X-ray.

Interventions

chest x-ray DIAGNOSTIC_TEST

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

Infants born to COVID-19 positive mothers

Eligibility Criteria

• Age: Up to 7 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

COVID-19; DiGeorge Syndrome

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; 22q11 Deletion Syndrome; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Lymphatic Abnormalities; Lymphatic Diseases; Hemic and Lymphatic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Hypoparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Seda Yilmaz Semerci

CONTACT

+905337180683; sedayilmazsemerci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 14, 2020
• Study Start: May 30, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)