Characteristics of Neonatal Covid-19 in Turkey

NCT04401540 | Unknown DMC

• 1 other identifier: NICU-COVID-TR
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Neonatal Disease; Healthy

Keywords

Vertical Transmission

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hospital stay

  First 28 days of life

• Early neonatal sepsis rate

  First 3 days

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Infants born to mothers with Covid-19 infection

You may not qualify if:

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

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead
• Turkish Neonatal Society: collaborator

Study Sites (1)

Recep Tayyip Erdogan University Medical School

Rize, 53200, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 32238084 RESULT

• 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.

  PMID: 32277162 RESULT

• 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.

  PMID: 32285380 RESULT

• 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.

  PMID: 35061093 DERIVED

• 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.

  PMID: 32776309 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal, endotracheal aspirates of the neonate for Covid-19 Placenta and blood and stool samples of the neonate Milk of the mother

MeSH Terms

Conditions

COVID-19; Infant, Newborn, Diseases

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mehmet K Kanburoglu, M.D.

  Head of Pediatrics and Neonatology, Associate Professor

  STUDY DIRECTOR

Central Study Contacts

Mehmet K Kanburoglu, M.D.

CONTACT

+905326685916; kanburoglumk@outlook.com

Mehmet Y Oncel, M.D.

CONTACT

+90532 631 51 85; dryekta@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, Neonatologist, Head of Pediatrics

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 26, 2020
• Study Start: May 1, 2020
• Primary Completion: October 30, 2020
• Study Completion: December 30, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication
• Access Criteria: The data will be shared in case of review requests from investigators who have an ORCHID account.

Locations

TU (1)