Antibiotic "Dysbiosis" in Preterm Infants

• Status: Completed
• Trial end date: 2019-09-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Society for Pediatric Dermatology
• Treatments: Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefotaxime; Cefoxitin; Gentamicins

Criteria

Inclusion Criteria:

• All infants less than 33 weeks gestation.

Exclusion Criteria:

• Infants who are non-viable at birth.