At a glance
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Antibiotic Effects on the Developing Microbiome, Metabolome and Morbidities in Preterm Neonates
In Brief
A Phase 2 clinical trial evaluating Antibiotic, Gastric fluid, and 3 other interventions for Enterocolitis, Necrotizing and 6 related conditions. Completed, enrolled 98 participants across 1 site.
Detailed Summary
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing enterocolitis (NEC), late-onset sepsis, bronchopulmonary dysplasia (BPD), and mortality. The hypothesis is that early and prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities. It is possible that the effect of this widespread antibiotic use outweighs the potential benefits. This study will randomize preterm infants born at less than 33 weeks gestation to either pre-emptive antibiotics or no-pre-emptive antibiotics. The purpose of this research is to evaluate the risks and benefits of current practice to determine optimal levels of antibiotic use that protects the babies from infection with minimal effect on the microbiome and subsequent adverse outcomes related to overuse of antibiotics.
Study Details
Timeline
Interventions
Babies that are assigned to antibiotics receive therapy based on the clinical team's discretion.
Microbiome evaluated using gastric aspirate.
Microbiome will be evaluated using mother's breast milk.
Microbiome will be evaluated using infant's stool.
Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.