Analysis of clinical outcomes and inflammatory markers in newborn children of pregnant women exposed to SARS-CoV-2: a case-control study

Newborn patients at the HUB and HRAN who meet the inclusion criteria in the study will be evaluated. These patients will be allocated to the exposed or unexposed group according to the maternal exams that classified them as exposed or not exposed to SARS-CoV-2 during the gestational period. Data from the Epidemiological Surveillance and Immunization Management (GVEI-DF) will be consulted daily. An estimated 300 patients are children of women and 300 patients are children of unexposed women. Data collection will end when this number is reached or sooner, depending on the evolution of the COVID-19 pandemic in the population. The umbilical cord blood will be collected immediately after the pulse stops. 4 ml of blood will be collected in a green heparinized tube that will be sent to the HUB laboratory for centrifugation and transfer of the serum to the cryotube. The cryotube will be stored in the HUB freezer for research materials. Inflammatory cytokines will be analyzed in the Dermatology laboratory of the Faculty of Medicine of the University of Brasília. The blood from the umbilical cord of patients coming from the Regional Hospital of Asa Norte (HRAN) will follow the same flow inside the laboratory of that hospital and will remain in the freezer of the same. This material will be redeemed and transferred to the HUB every 48 hours. The blood from the umbilical cord of patients coming from the Regional Hospital of Asa Norte (HRAN) will follow the same flow inside the laboratory of that hospital and will remain in the freezer of the same. This material will be redeemed and transferred to the HUB every 48 hours. The blood from the umbilical cord of patients coming from the Regional Hospital of Asa Norte (HRAN) will follow the same flow inside the laboratory of that hospital and will remain in the freezer of the same. This material will be redeemed and transferred to the HUB every 48 hours. At birth, this newborn will have two possible destinations, the joint accommodation of the maternity ward or the neonatal intensive care unit. Data for each patient begins to be collected at birth and ends at discharge. If any patient in the study is submitted to lumbar puncture for CSF analysis by medical indication, from this material a small sample will be collected for analysis of inflammatory cytokines. After discharge, these patients will be referred to the BORN Multidisciplinary Clinic. This clinic was created exclusively for the purposes of the study. The service will operate on Fridays from 1 pm to 6 pm in the Orange Corridor of the HUB. The patient will undergo monthly pediatric follow-up until the sixth month and perform auditory evoked potential, transfontanellar ultrasound and neurodevelopment assessment with the Bailey Scale at 1, 3 and 6 months. The data will be stored in a specific spreadsheet. All study data will be stored using the RedCap platform.