Antibiotic "Dysbiosis" in Preterm Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Bronchitis, Colitis, Infectious Disease, Neurology, Ocular, Gastrointestinal, Pulmonary, Hematology |
| Therapuetic Areas: | Gastroenterology, Hematology, Immunology / Infectious Diseases, Neurology, Ophthalmology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/14/2018 |
| Start Date: | January 2017 |
| End Date: | December 2019 |
| Contact: | Kelly Curry, MSN |
| Email: | hernack1@ufl.edu |
| Phone: | 352 273 8979 |
Antibiotic Effects on the Developing Microbiome, Metabolome and Morbidities in Preterm Neonates
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.
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.
A majority of preterm very low birthweight (VLBW) infants are exposed to antibiotics. Surveys
from large databases in the US show that the rate of culture proven bacteremia in these
infants at birth is only between 1-2 percent.
Antibiotic use, especially when repeated, induces a perturbation ("dysbiosis") in gut
microbiota that may not recover to the basal state. Antibiotic use increases the risk of
subsequent disease and adverse outcomes. The dependence of the developing immune system on
the intestinal microbiota is supported by emerging evidence from studies in animals
demonstrating decreased resistance to subsequent disease with early exposure to antibiotics.
A retrospective review of 50,0261 neonates across 127 neonatal intensive care units (NICUs)
from California showed a forty-fold variation in NICU antibiotic prescribing practice with
similar burdens of proven infection and mortality. A large number of preterm infants are thus
subjected to a potentially harmful course of antibiotics that provides no clear benefit.
There remains a major gap in our understanding of antibiotic-related intestinal microbial
dysbiosis and how this may result in disease.
There will be two aims. In the first aim, a prospective, randomized pilot study, will test
the effects of pre-emptive postnatal antibiotics on the microbiome, metabolome and
inflammatory responses in the neonate during the NICU course. The second aim will assess the
effects of pre-emptive postnatal antibiotics on adverse outcomes in the neonate while in the
NICU. The hypothesis is that higher antibiotic use will not be associated with decreased
early onset sepsis and in fact, will be associated with increased adverse outcomes including
retinopathy of prematurity, necrotizing enterocolitis, spontaneous ileal perforation, late
onset sepsis, chronic lung disease, bronchopulmonary dysplasia, intraventricular hemorrhage,
periventricular leukomalacia, and mortality.
from large databases in the US show that the rate of culture proven bacteremia in these
infants at birth is only between 1-2 percent.
Antibiotic use, especially when repeated, induces a perturbation ("dysbiosis") in gut
microbiota that may not recover to the basal state. Antibiotic use increases the risk of
subsequent disease and adverse outcomes. The dependence of the developing immune system on
the intestinal microbiota is supported by emerging evidence from studies in animals
demonstrating decreased resistance to subsequent disease with early exposure to antibiotics.
A retrospective review of 50,0261 neonates across 127 neonatal intensive care units (NICUs)
from California showed a forty-fold variation in NICU antibiotic prescribing practice with
similar burdens of proven infection and mortality. A large number of preterm infants are thus
subjected to a potentially harmful course of antibiotics that provides no clear benefit.
There remains a major gap in our understanding of antibiotic-related intestinal microbial
dysbiosis and how this may result in disease.
There will be two aims. In the first aim, a prospective, randomized pilot study, will test
the effects of pre-emptive postnatal antibiotics on the microbiome, metabolome and
inflammatory responses in the neonate during the NICU course. The second aim will assess the
effects of pre-emptive postnatal antibiotics on adverse outcomes in the neonate while in the
NICU. The hypothesis is that higher antibiotic use will not be associated with decreased
early onset sepsis and in fact, will be associated with increased adverse outcomes including
retinopathy of prematurity, necrotizing enterocolitis, spontaneous ileal perforation, late
onset sepsis, chronic lung disease, bronchopulmonary dysplasia, intraventricular hemorrhage,
periventricular leukomalacia, and mortality.
Inclusion Criteria:
- All infants less than 33 weeks gestation.
Exclusion Criteria:
- Infants who are non-viable at birth.
We found this trial at
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