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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
27
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.
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.
Normal saline will be given as placebo for those in the placebo comparator group.
University of Chicago Medical Center - Comer Children's Hospital
Chicago, Illinois, United States
Richness of the Preterm Infant Microbiome
Number of 16S rRNA gene amplicon sequence variants (i.e., proxy for prokaryote species-like groupings) detected in each sample. A higher richness means that a higher number of species of archaea and bacteria was detected in a sample.
Time frame: 2 weeks
Shannon Diversity of the Preterm Infant Microbiome
Function of richness and evenness of 16S rRNA gene amplicon sequence variants (i.e., proxy for prokaryote species-like groupings) within each sample. A higher Shannon diversity means that a sample had a combination of a higher number of species of archaea and bacteria, and/or a more even relative abundance of those species within a sample.
Time frame: 2 weeks
Chronic Lung Disease of Infancy (CLD)
Premature infants who require \> 21% FiO2 for at least 28 days and/or at 36 weeks corrected gestation
Time frame: 4-12 weeks
Necrotizing Enterocolitis (NEC)
Any patient showing signs/symptoms of this acute neonatal gastrointestinal disease, including abdominal distension, bloody stools, systemic illness, and radiographic changes (pneumatosis intestinalis, portal venous gas, free intraperitoneal gas).
Time frame: 4-12 weeks
Retinopathy of Prematurity (ROP)
Cases of ROP as diagnosed by the pediatric ophthalmologist
Time frame: 4-12 weeks
Intraventricular Hemorrhage (IVH)
Cases of IVH present on any head ultrasound obtained during patient's hospitalization
Time frame: 4-12 weeks
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Death
Time frame: 18 months