Condition: Chorioamnionitis · Chorioamnionitis Affecting Fetus or Newborn · Necrotizing Enterocolitis of Newborn · Sponsor: Maxima Medical Center
Background: Necrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations. An important yet understudied contributor in the development of the gastrointestinal tract (GIT) is amniotic fluid (AF). Knowledge is lacking on the critical shifts that may occur in AF in extremely preterm birth. The aim of the current study is to assess the composition of AF using advanced biomedical techniques. Secondary objectives are to assess AF profiles of infants with chorioamnionitis (CAM) and/or fetal growth restriction (FGR), assess key metabolites across gestation, correlate AF profiles with neonatal outcomes, and explore associations with early gut microbiota. Methods: ln 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), either during vaginal delivery or cesarean section (CS). Additionally, AF samples will be collected from a reference group (n=150), including early midtrimester (GA \<23+/7 weeks), very early and moderate to late preterm (GA 28+0/6-36+6/7 weeks), and full-term pregnancies (GA 37+0/7-41+6/7 weeks). Thorough characterization of AF will be conducted, including microbial profiling and metabolomics. Microbiota profiling of neonatal fecal samples will be conducted to assess the association between AF and early neonatal gut colonization patterns. Discu…
This description comes directly from the study's public registry record.
Mirjam M. van Weissenbruch · 020 566 9111 · m.vanweissenbruch@amsterdamumc.nl
Hendrik Niemarkt, dr
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| Amsterdam UMC | Amsterdam, Netherlands | Recruiting |
| Máxima Medical Center | Veldhoven, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07152106