CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Ampicillin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02477423
NCT02477423N/ACompleted

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

University of Chicago·interventional·Posted Jun 22, 2015·Updated Oct 8, 2020

In Brief

A clinical study evaluating Ampicillin, Gentamicins, and 1 other intervention for Premature Birth of Newborn and Enterocolitis, Necrotizing. Completed, enrolled 27 participants across 1 site.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 22, 2015
Enrollment StartJul 1, 2015
Primary CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.0 years ago

Interventions

Ampicillindrug

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.

Gentamicinsdrug

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.

Placebodrug

Normal saline will be given as placebo for those in the placebo comparator group.