Characteristics of Neonatal Covid-19 in Turkey

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04401540

Enrollment

Registered

2020-05-26

Start date

2020-05-01

Completion date

2020-12-30

Last updated

2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Healthy, Neonatal Disease

Keywords

Vertical Transmission

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Vertical Transmission	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

Secondary

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

Countries

Turkey (Türkiye)

Contacts

Primary ContactMehmet K Kanburoglu, M.D.

kanburoglumk@outlook.com+905326685916

Backup ContactMehmet Y Oncel, M.D.

dryekta@gmail.com+90532 631 51 85

Outcome results