Characteristics of Neonatal Covid-19 in Turkey

NCT ID: NCT04401540

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-12-30

Brief Summary

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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

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

Conditions

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COVID-19 Neonatal Disease Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Turkish Neonatal Society

OTHER

Sponsor Role collaborator

Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Kenan Kanburoglu

Associate Professor of Pediatrics, Neonatologist, Head of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet K Kanburoglu, M.D.

Role: STUDY_DIRECTOR

Head of Pediatrics and Neonatology, Associate Professor

Locations

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Recep Tayyip Erdogan University Medical School

Rize, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet K Kanburoglu, M.D.

Role: CONTACT

+905326685916

Mehmet Y Oncel, M.D.

Role: CONTACT

+90532 631 51 85

Facility Contacts

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Mehmet K Kanburoglu, M.D.

Role: primary

+905326685916

References

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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.

Reference Type RESULT
PMID: 32238084 (View on PubMed)

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.

Reference Type RESULT
PMID: 32277162 (View on PubMed)

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.

Reference Type RESULT
PMID: 32285380 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35061093 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32776309 (View on PubMed)

Other Identifiers

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NICU-COVID-TR

Identifier Type: -

Identifier Source: org_study_id

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