The impact of AMniotic FluId on the development and microBIal colonization of the prEterm intestinal tract (AMFIBIE): study protocol for a multicenter prospective cohort study

Introduction Prematurity is associated with intestinal immaturity and gut microbiota alterations, both of which are linked to necrotizing enterocolitis (NEC) and sepsis. An important yet understudied contributor in the development of the gastrointestinal (GI) tract is amniotic fluid (AF). The aim of this study is to assess the composition of AF collected during extremely preterm birth. Secondary objectives are to identify AF profiles of pregnancies complicated with chorioamnionitis and/or fetal growth restriction, assess key AF components across gestation, correlate AF profiles with neonatal outcomes (e.g., NEC and sepsis), and explore associations with neonatal gut microbiota. Methods and analysis In this multicenter prospective cohort study, AF (∼5 mL) will be collected from obstetric patients delivering their infants extremely preterm [gestational age (GA) 24 + 0/7–27 + 6/7 weeks, n = 125]. AF can be collected safely and non-invasively during vaginal delivery or cesarean section. AF samples will also be collected from a reference group (GA