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

Not Applicable

Completed

• Conditions: Premature Birth of Newborn; Enterocolitis, Necrotizing
• Interventions: Drug: Placebo; Drug: Ampicillin; Drug: Gentamicins

• Registration Number: NCT02477423
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-22
• Study Start: 2015-07
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Results First Submitted: 2020-06-19
• Results First Submitted QC: 2020-08-18
• Status Verified: 2020-09
• Results First Posted: 2020-09-03
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized & Blinded - Receiving Antibiotics	Gentamicins	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.
Randomized & Blinded - Receiving Placebo	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.
Randomized & Blinded - Receiving Antibiotics	Ampicillin	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.

Primary Outcome Measures

Name	Time	Method
Shannon Diversity of the Preterm Infant Microbiome	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	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 Outcome Measures

Name	Time	Method
Chronic Lung Disease of Infancy (CLD)	4-12 weeks	Premature infants who require \> 21% FiO2 for at least 28 days and/or at 36 weeks corrected gestation
Intraventricular Hemorrhage (IVH)	4-12 weeks	Cases of IVH present on any head ultrasound obtained during patient's hospitalization
Death	18 months
Necrotizing Enterocolitis (NEC)	4-12 weeks	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).
Retinopathy of Prematurity (ROP)	4-12 weeks	Cases of ROP as diagnosed by the pediatric ophthalmologist

Trial Locations

Locations (1)

University of Chicago Medical Center - Comer Children's Hospital; 🇺🇸 Chicago, Illinois, United States