Clinical trial NCT04401540: Characteristics of Neonatal Covid-19 in Turkey
Official title: Clinical and Epidemiological Characteristics of COVID-19 Infection on Babies of Prenatal COVID-19 Positive Women in Turkey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Neonatal Disease
Healthy
Keywords: Vertical Transmission
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Turkish Neonatal Society
First posted: 2020-05-26
Enrollment: 90
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vertical Transmission
timeFrame: First 28 days of life
Secondary outcomes:
measure: Hospital stay
timeFrame: First 28 days of life
measure: Early neonatal sepsis rate
timeFrame: First 3 days
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Medical School
Study officials:
affiliation: Head of Pediatrics and Neonatology, Associate Professor
name: Mehmet K Kanburoglu, M.D.
role: STUDY_DIRECTOR
References:
citation: 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):246-250. doi: 10.1080/15513815.2020.1747120. Epub 2020 Apr 2.
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 2020 Apr 10.
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.
citation: Akin IM, Kanburoglu MK, Tayman C, Oncel MY, Imdadoglu T, Dilek M, Yaman A, Narter F, Er I, Kahveci H, Erdeve O, Koc E; Neo-Covid Study Group. Epidemiologic and clinical characteristics of neonates with late-onset COVID-19: 1-year data of Turkish Neonatal Society. Eur J Pediatr. 2022 May;181(5):1933-1942. doi: 10.1007/s00431-021-04358-8. Epub 2022 Jan 21.
citation: Oncel MY, Akin IM, Kanburoglu MK, Tayman C, Coskun S, Narter F, Er I, Oncan TG, Memisoglu A, Cetinkaya M, Oguz D, Erdeve O, Koc E; Neo-Covid Study Group. A multicenter study on epidemiological and clinical characteristics of 125 newborns born to women infected with COVID-19 by Turkish Neonatal Society. Eur J Pediatr. 2021 Mar;180(3):733-742. doi: 10.1007/s00431-020-03767-5. Epub 2020 Aug 10.