Characteristics of Neonatal Covid-19 in Turkey
- Conditions
- Neonatal DiseaseHealthyCOVID-19
- Registration Number
- NCT04401540
- Lead Sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- Infants born to mothers with Covid-19 infection
- If PCR values of mother negative, even though the clinic is preferable for Covid-19, the infant will not be recruited.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vertical Transmission 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
- Secondary Outcome Measures
Name Time Method Early neonatal sepsis rate First 3 days Early neonatal sepsis rate
Hospital stay First 28 days of life Hospital span time of the neonates in NICU
Trial Locations
- Locations (1)
Recep Tayyip Erdogan University Medical School
🇹🇷Rize, Turkey