Characteristics of Neonatal Covid-19 in Turkey

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04401540
• Other study ID #: NICU-COVID-TR
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2020
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: Mehmet K Kanburoglu, M.D.
• Phone: +905326685916
• Email: kanburoglumk[@]outlook.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Healthy
• Infant, Newborn, Diseases
• Neonatal Disease

Locations

Country	Name	City	State
Turkey	Recep Tayyip Erdogan University Medical School	Rize

Sponsors (2)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital	Turkish Neonatal Society

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Karimi-Zarchi M, Neamatzadeh H, Dastgheib SA, Abbasi H, Mirjalili SR, Behforouz A, Ferdosian F, Bahrami R. Vertical Transmission of Coronavirus Disease 19 (COVID-19) from Infected Pregnant Mothers to Neonates: A Review. Fetal Pediatr Pathol. 2020 Jun;39(3 — View Citation

Liu W, Wang J, Li W, Zhou Z, Liu S, Rong Z. Clinical characteristics of 19 neonates born to mothers with COVID-19. Front Med. 2020 Apr;14(2):193-198. doi: 10.1007/s11684-020-0772-y. Epub 2020 Apr 13. — View Citation

Mimouni F, Lakshminrusimha S, Pearlman SA, Raju T, Gallagher PG, Mendlovic J. Perinatal aspects on the covid-19 pandemic: a practical resource for perinatal-neonatal specialists. J Perinatol. 2020 May;40(5):820-826. doi: 10.1038/s41372-020-0665-6. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertical Transmission	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	Hospital stay	Hospital span time of the neonates in NICU	First 28 days of life
Secondary	Early neonatal sepsis rate	Early neonatal sepsis rate	First 3 days