COVID-19NCT04401540
Characteristics of Neonatal Covid-19 in Turkey
An observational study of COVID-19 and Neonatal Disease, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Neonatal Disease, Healthy
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 30 Dec 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: The investigators will try to recruit all the babies that will be born to mothers with Covid-19 disease across Turkey.
Who may be able to join
- Infants born to mothers with Covid-19 infection
Who cannot join
- If PCR values of mother negative, even though the clinic is preferable for Covid-19, the infant will not be recruited.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Recep Tayyip Erdogan University Medical School
Rize, 53200
Mehmet K Kanburoglu, M.D., +905326685916, kanburoglumk@outlook.com
About this study
Official title: Clinical and Epidemiological Characteristics of COVID-19 Infection on Babies of Prenatal COVID-19 Positive Women in Turkey
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.
Read the 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.
- Conditions
- COVID-19, Neonatal Disease, Healthy
- Keywords
- Vertical Transmission
- Medical subject headings
- COVID-19, Infant, Newborn, Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First 28 days of life
Secondary outcomes (2)
Hospital stay
Hospital span time of the neonates in NICU
Measured: First 28 days of life
Early neonatal sepsis rate
Early neonatal sepsis rate
Measured: First 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 May 2020
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Neonatal Society
- Responsible party
- Principal investigator, Mehmet Kenan Kanburoglu, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Mehmet K Kanburoglu, M.D., Study director, Head of Pediatrics and Neonatology, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401540
- Sponsor's protocol ID
- NICU-COVID-TR
- Status last verified
- Jul 2020
- First submitted
- 22 May 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
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.
PubMed 32238084Mimouni 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.
PubMed 32277162Liu 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.
PubMed 32285380Akin 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.
PubMed 35061093Oncel 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.
PubMed 32776309
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Epidemiological Characteristics of COVID-19 Infection on Babies of Prenatal COVID-19 Positive Women in Turkey
- ClinicalTrials.gov ID
- NCT04401540
- Acronym / sponsor ID
- NICU-COVID-TR
- Conditions
- COVID-19, Neonatal Disease, Healthy
- Keywords
- Vertical Transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Collaborators
- Turkish Neonatal Society
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The investigators will try to recruit all the babies that will be born to mothers with Covid-19 disease across Turkey.
Key inclusion criteria (1 listed)
- Infants born to mothers with Covid-19 infection
Key exclusion criteria (1 listed)
- If PCR values of mother negative, even though the clinic is preferable for Covid-19, the infant will not be recruited.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vertical Transmission
Time frame: 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
2 secondary outcomes
Hospital stay
Time frame: First 28 days of life
Early neonatal sepsis rate
Time frame: First 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Results publication: PubMed 32238084Karimi-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.
- Results publication: PubMed 32277162Mimouni 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.
- Results publication: PubMed 32285380Liu 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.
- Derived from this study: PubMed 35061093Akin 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.
- Derived from this study: PubMed 32776309Oncel 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet K Kanburoglu, M.D. study director
Head of Pediatrics and Neonatology, Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Neonatal Disease, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet K Kanburoglu, M.D. (+905326685916, kanburoglumk@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical Transmission (time frame: First 28 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04401540, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.