Characteristics of Neonatal Covid-19 in Turkey

July 13, 2020 updated by: Mehmet Kenan Kanburoglu, Recep Tayyip Erdogan University Training and Research Hospital

Clinical and Epidemiological Characteristics of COVID-19 Infection on Babies of Prenatal COVID-19 Positive Women in Turkey

The investigators aimed to investigate the clinical and epidemiological characteristics of neonates who will be born to Covid-19 positive mothers in Turkey. It is a multicentric prospective cohort study designed and destined only in Turkey. The investigators are planning to admit more than 20 Neonatal Intensive Care Units into the survey; nevertheless, the total number may change according to the prevalence of Covid-19 in neonates.

The investigators will also inquire into vertical transmission by collecting cord blood, placental, and postnatal serum samples to test for Covid-19 PCR and Covid-19 Ig M and IgG values from the neonates.

Study Overview

Status

Unknown

Conditions

Detailed Description

The patients will be recruited by a secure database of "Trials Network" with individualized accounts. Plexus Corporation will hold data monitoring and primary analysis.

Study Type

Observational

Enrollment (Anticipated)

90

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 Contact Backup

Study Locations

  • Turkey
      • Rize, Turkey, 53200
        • Recruiting
        • Recep Tayyip Erdogan University Medical School
        • 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 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The investigators will try to recruit all the babies that will be born to mothers with Covid-19 disease across Turkey.

Description

Inclusion Criteria:

  • Infants born to mothers with Covid-19 infection

Exclusion Criteria:

  • If PCR values of mother negative, even though the clinic is preferable for Covid-19, the infant will not be recruited.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertical Transmission
Time Frame: First 28 days of life
Vertical transmission will be investigated by obtaining neonatal PCR samples in blood, stool and mother milk as well as Neonatal Covid-19 Ig M and Ig G values
First 28 days of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: First 28 days of life
Hospital span time of the neonates in NICU
First 28 days of life
Early neonatal sepsis rate
Time Frame: First 3 days
Early neonatal sepsis rate
First 3 days

Collaborators and Investigators

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

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Collaborators

Turkish Neonatal Society

Investigators

  • Study Director: Mehmet K Kanburoglu, M.D., Head of Pediatrics and Neonatology, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2020

Primary Completion (Anticipated)

October 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 26, 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICU-COVID-TR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

The data will be shared in case of review requests from investigators who have an ORCHID account.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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