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

NCT02477423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-10-08

Study results available
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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

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.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
6 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02477423 on ClinicalTrials.gov