# The NICU Antibiotics and Outcomes (NANO) Trial

> **NIH NIH R01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2021 · $499,628

## Abstract

ABSTRACT
The goal of the NANO (NICU Antibiotics and Outcomes) Trial is to study the longstanding clinical practice of
empirically administering intravenous antibiotics to newborn extremely low birthweight (ELBW) infants. ELBW
infants commonly receive antibiotics immediately after birth and then for 2-3 subsequent days while clinicians
await microbiology culture results. Typically, these culture results are used to guide a decision to continue or
discontinue antibiotics based on the presence or absence of a bloodstream infection. The assumption underlying
this practice is that early antibiotic administration will improve outcomes in infants undergoing evaluation for
early onset sepsis (EOS). However, there are no data to support or refute this assumption, and numerous
studies have shown that >98% of ELBW infants receiving empiric antibiotics (EA) do not have EOS. Recent
microbiome research has demonstrated that broad-spectrum antibiotic exposure is associated with adverse
childhood outcomes, and this may be particularly relevant during a critical window of early bacterial colonization
in newborns. We simply do not know whether early EA for ELBW infants improves health outcomes, worsens
outcomes, or does not affect outcomes. Data from our group and others document the impact of antibiotics on
microbiome development and demonstrate a dose-dependent association between antibiotic days and a
composite outcome of late onset sepsis (LOS), necrotizing enterocolitis (NEC), or death in ELBW infants.
To formally study whether the incidence of adverse outcomes is higher in infants receiving EA in the first week
of life compared to babies receiving placebo, we propose the NANO Trial, an 802-subject placebo-controlled
multicenter randomized clinical trial. We target a population of infants for whom the clinical decision to use or
not use EA is most challenging in 2018. We will enroll clinically stable ELBW infants with gestational age ≤28
weeks, excluding those at high risk for EOS (e.g. suspected exposure to intraamniotic infection) and those at
low risk for EOS (e.g. delivery via uncomplicated caesarean section for maternal indications). The aims of the
study are (1) To test the hypothesis that the composite incidence of LOS, NEC, or death in infants that receive
EA is significantly different than the incidence among infants that receive placebo, (2) To test the hypothesis that
fecal samples in the first month of life from infants receiving EA will contain lower diversity and higher abundance
of pathogens than fecal samples from infants receiving placebo, and (3) To compare somatic growth (weekly
weight and length z-scores) in infants receiving EA and infants receiving placebo (exploratory aim). The results
from this study may validate current clinical practice patterns regarding antibiotic administration, or they may
provide a critical rationale for further reducing antibiotic usage in the NICU. In addition to improving outcomes
for individual babies by red...

## Key facts

- **NIH application ID:** 10213792
- **Project number:** 5R01HD097578-03
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Anup C Katheria
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $499,628
- **Award type:** 5
- **Project period:** 2019-09-13 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10213792

## Citation

> US National Institutes of Health, RePORTER application 10213792, The NICU Antibiotics and Outcomes (NANO) Trial (5R01HD097578-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10213792. Licensed CC0.

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