Examining the immune signatures of SARS-CoV-2 infection in pregnancy and the impact on neurodevelopment: Protocol of the SIGNATURE longitudinal study
Authors: Garrido-Torres Nathalia , Cerrillos Lucas , García Cerro Susana , Pérez Gómez Alberto , Canal-Rivero Manuel , de Felipe Beatriz , Alameda Luis , Marqués Rodríguez Renata , Anillo Sergio , Praena Julia , Duque Sánchez Cristina , Roca Cristina , Paniagua María , López Díaz Alvaro , Romero-García Rafael , Olbrich Peter , Puertas Albarracín Martín de Porres , Reguera Pozuelo Pablo , Sosa Irene Luján , Moreno Dueñas María Begoña , Pineda Cachero Rocío , Zamudio Juan Lidia , García Rumi Verónica , Guerrero Benitez Mercedes , Figueroa Rosario , Martín Rendón Antonio Manuel , Partida Antonio , Rodríguez Cocho María Isabel , Gallardo Trujillo Carmen , Gallego Jiménez Isabel , García Spencer Sarah , Gómez Verdugo Marta , Bermejo Fernández Cintia , Pérez Benito María , Castillo Reina Rafael Esteban , Cejudo López Angela , Sánchez Tomás Candela , Chacón Gamero María Ángeles , Rubio Ana , Moreno Mellado Amanda , Ramos Herrero Víctor , Starr Ella , González Fernández de Palacios Marta , García Victori Elena , Pavón Delgado Antonio , Fernández Cuervo Ismael , Arias Ruiz Alejandro , Menéndez Gil Irene Esperanza , Domínguez Gómez Inés , Coca Mendoza Itziar , Ayesa-Arriola Rosa , Fañanas Lourdes , Leza Juan C , Cisneros José M , Sánchez Céspedes Javier , Ruiz-Mateos Ezequiel , Crespo-Facorro Benedicto , Ruiz-Veguilla Miguel 
Published: December 2022

The COVID-19 pandemic represents a valuable opportunity to carry out cohort studies that allow us to advance our knowledge on pathophysiological mechanisms of neuropsychiatric diseases. One of these opportunities is the study of the relationships between inflammation, brain development and an increased risk of suffering neuropsychiatric disorders. Based on the hypothesis that neuroinflammation during early stages of life is associated with neurodevelopmental disorders and confers a greater risk of developing neuropsychiatric disorders, we propose a cohort study of SARS-CoV-2-infected pregnant women and their newborns. The main objective of SIGNATURE project is to explore how the presence of prenatal SARS-CoV-2 infection and other non-infectious stressors generates an abnormal inflammatory activity in the newborn. The cohort of women during the COVID-19 pandemic will be psychological and biological monitored during their pregnancy, delivery, childbirth and postpartum. The biological information of the umbilical cord (foetus blood) and peripheral blood from the mother will be obtained after childbirth. These samples and the clinical characterisation of the cohort of mothers and newborns, are tremendously valuable at this time. This is a protocol report and no analyses have been conducted yet, being currently at, our study is in the recruitment process step. At the time of this publication, we have identified 1,060 SARS-CoV-2 infected mothers and all have already given birth. From the total of identified mothers, we have recruited 537 SARS-COV-2 infected women and all of them have completed the mental health assessment during pregnancy. We have collected biological samples from 119 mothers and babies. Additionally, we have recruited 390 non-infected pregnant women.