Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
98 participants
INTERVENTIONAL
2017-01-16
2019-09-11
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A - Antibiotics Indicated
These neonates have a clinical indication to receive antibiotics such as symptoms out of expected for gestation OR delivered to moms with high perinatal infectious risks.
The standard of care antibiotics include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Antibiotic
Babies that are assigned to antibiotics receive therapy based on the clinical team's discretion.
Gastric fluid
Microbiome evaluated using gastric aspirate.
Breast milk
Microbiome will be evaluated using mother's breast milk.
Stool samples
Microbiome will be evaluated using infant's stool.
Group B - antibiotics not indicated
These neonates are asymptomatic AND are delivered to moms with low perinatal infectious risk factors.
Antibiotics is not indicated for this group as standard of care.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid
Microbiome evaluated using gastric aspirate.
Breast milk
Microbiome will be evaluated using mother's breast milk.
Stool samples
Microbiome will be evaluated using infant's stool.
Group CI/randomized to antibiotics
This group will be randomized to receive standard of care antibiotics which include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid
Microbiome evaluated using gastric aspirate.
Breast milk
Microbiome will be evaluated using mother's breast milk.
Stool samples
Microbiome will be evaluated using infant's stool.
Antibiotics
Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.
Group CII/randomized to no antibiotics
This group will be randomized not to receive standard of care antibiotics.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid
Microbiome evaluated using gastric aspirate.
Breast milk
Microbiome will be evaluated using mother's breast milk.
Stool samples
Microbiome will be evaluated using infant's stool.
Interventions
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Antibiotic
Babies that are assigned to antibiotics receive therapy based on the clinical team's discretion.
Gastric fluid
Microbiome evaluated using gastric aspirate.
Breast milk
Microbiome will be evaluated using mother's breast milk.
Stool samples
Microbiome will be evaluated using infant's stool.
Antibiotics
Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
23 Weeks
33 Weeks
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Society for Pediatric Dermatology
OTHER
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Josef Neu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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References
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Ojeda A, Akinsuyi O, McKinley KL, Xhumari J, Triplett EW, Neu J, Roesch LFW. Increased antibiotic resistance in preterm neonates under early antibiotic use. mSphere. 2024 Oct 29;9(10):e0028624. doi: 10.1128/msphere.00286-24. Epub 2024 Oct 7.
Singh NK, Will L, Al-Mulaabed S, Ruoss L, Li N, de La Cruz D, Gurka M, Neu J. Antibiotics Use and Its Effects on the Establishment of Feeding Tolerance in Preterm Neonates. Am J Perinatol. 2024 May;41(S 01):e2248-e2253. doi: 10.1055/a-2108-1960. Epub 2023 Jun 12.
Russell JT, Lauren Ruoss J, de la Cruz D, Li N, Bazacliu C, Patton L, McKinley KL, Garrett TJ, Polin RA, Triplett EW, Neu J. Antibiotics and the developing intestinal microbiome, metabolome and inflammatory environment in a randomized trial of preterm infants. Sci Rep. 2021 Jan 21;11(1):1943. doi: 10.1038/s41598-021-80982-6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB201501045-N
Identifier Type: -
Identifier Source: org_study_id
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