NCT02477423

A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 6 Hours
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.

Conditions

• Premature Birth of Newborn
• Enterocolitis, Necrotizing

Interventions

Type	Name	Description
DRUG	Ampicillin	Ampicillin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization.
DRUG	Gentamicins	Gentamicin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization.
DRUG	Placebo	Normal saline will be given as placebo for those in the placebo comparator group.

Timeline

• Start date: 2015-07-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2015-06-22
• Last updated: 2020-10-08
• Results posted: 2020-09-03

Locations

1 site across 1 country: United States