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Clinical Trials/NCT02477423
NCT02477423CompletedNot Applicable

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

University of Chicago1 site in 1 country27 target enrollmentStarted: July 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Active Comparator

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

Active Comparator

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

Placebo Comparator

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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