Routine antibiotic use in preterm neonates: a randomised controlled trial

Area of Science:

• Neonatalogy
• Pediatric Infectious Diseases
• Clinical Microbiology

Background:

• Preterm neonates possess immature immune systems, increasing their susceptibility to neonatal sepsis.
• Early-life antibiotic exposure is a concern due to potential long-term effects on the microbiome and resistance development.

Purpose of the Study:

• To evaluate the efficacy of routine antibiotic administration in preventing clinical sepsis among preterm neonates.
• To assess the impact of routine antibiotics on secondary outcomes including positive blood cultures, necrotizing enterocolitis, mortality, and hospital stay.

Main Methods:

• A part-blinded, randomized controlled trial was conducted.
• Preterm neonates admitted within 12 hours of life, without other infection risk factors, were assigned to either routine antibiotics or a control group (antibiotics only if clinically indicated).
• Primary outcome was clinical sepsis incidence; secondary outcomes included positive blood cultures, necrotizing enterocolitis (NEC) stage II/III, death, and hospital stay duration.

Main Results:

• Clinical sepsis incidence was similar between the antibiotic group (31.9%) and the control group (25.4%; P=0.392).
• Mortality rates were equivalent in both groups.
• The control group exhibited a significantly higher incidence of positive blood cultures (P=0.002).
• Necrotizing enterocolitis and hospital stay duration were comparable across both groups.

Conclusions:

• Routine antibiotic administration in low-risk preterm neonates does not appear to offer a protective effect against clinical sepsis.
• The findings suggest that withholding routine antibiotics in this specific population may be a viable strategy, although careful monitoring for positive blood cultures is warranted.