Antibiotic "Dysbiosis" in Preterm Infants

Summary

Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing enterocolitis (NEC), late-onset sepsis, bronchopulmonary dysplasia (BPD), and mortality.

The hypothesis is that early and prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities. It is possible that the effect of this widespread antibiotic use outweighs the potential benefits. This study will randomize preterm infants born at less than 33 weeks gestation to either pre-emptive antibiotics or no-pre-emptive antibiotics.

The purpose of this research is to evaluate the risks and benefits of current practice to determine optimal levels of antibiotic use that protects the babies from infection with minimal effect on the microbiome and subsequent adverse outcomes related to overuse of antibiotics.

Conditions

• Enterocolitis, Necrotizing
• Bacteremia
• Bronchopulmonary Dysplasia
• Intraventricular Hemorrhage
• Periventricular Leukomalacia
• Chronic Lung Disease
• Ileal Perforation

Interventions

DRUG

Antibiotic

Babies that are assigned to antibiotics receive therapy based on the clinical team's discretion.

OTHER

Gastric fluid

Microbiome evaluated using gastric aspirate.

OTHER

Breast milk

Microbiome will be evaluated using mother's breast milk.

OTHER

Stool samples

Microbiome will be evaluated using infant's stool.

DRUG

Antibiotics

Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Society for Pediatric Dermatology

  collaborator OTHER

• University of Florida

  lead OTHER

Principal Investigators

• Josef Neu, MD · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

23 Weeks

Max Age

33 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-16

Primary Completion

2019-09-11

Completion

2019-09-11

FDA Drug

Yes

Countries

• United States

Study Locations