A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Shannon Diversity of the Preterm Infant Microbiome
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- — to 6 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Randomized & Blinded - Receiving Antibiotics
The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive routine ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.
Intervention: Ampicillin (Drug)
Randomized & Blinded - Receiving Antibiotics
The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive routine ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.
Intervention: Gentamicins (Drug)
Randomized & Blinded - Receiving Placebo
The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive placebo (saline) in place of ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Shannon Diversity of the Preterm Infant Microbiome
Time Frame: 2 weeks
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.
Richness of the Preterm Infant Microbiome
Time Frame: 2 weeks
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.
Secondary Outcomes
- Chronic Lung Disease of Infancy (CLD)(4-12 weeks)
- Intraventricular Hemorrhage (IVH)(4-12 weeks)
- Death(18 months)
- Necrotizing Enterocolitis (NEC)(4-12 weeks)
- Retinopathy of Prematurity (ROP)(4-12 weeks)