ArticleFrontiers in pediatrics2025
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.
Article in Frontiers in pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07152106 (The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study
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Authors and funding
10 authors.
Funding
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Abstract
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, Ethics and disseminations: Ethical approval was received by the METC of the Máxima Medical Center in Veldhoven, the Netherlands (W24.042). The study was registered in a public clinical trial registry (NCT07152106). Study findings will be disseminated through peer-reviewed journal articles as well as national and international conference presentations. Clinical Trial Registration: https://clinicaltrials.gov/study/NCT07152106, identifier NCT07152106.
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