Accepted Manuscript

A Standardized Guideline for Antibiotic Prophylaxis in Surgical

Neonates

Carrie Laituri MD , Meghan A. Arnold MD

PII: S1055-8586(19)30009-5
DOI: https://doi.org/10.1053/j.sempedsurg.2019.01.009
Reference: YSPSU 50790

To appear in: Seminars in Pediatric Surgery

Please cite this article as: Carrie Laituri MD , Meghan A. Arnold MD , A Standardized Guide-
line for Antibiotic Prophylaxis in Surgical Neonates, Seminars in Pediatric Surgery (2019), doi:
https://doi.org/10.1053/j.sempedsurg.2019.01.009

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 ACCEPTED MANUSCRIPT

A Standardized Guideline for Antibiotic Prophylaxis in Surgical Neonates

a b
Carrie Laituri, MD and Meghan A. Arnold, MD

a
Carrie Laituri, MD

Joe DiMaggio Children’s Hospital

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Memorial Healthcare System

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Hollywood, FL

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b
Meghan A. Arnold, MD

CS Mott Children’s Hospital

Michigan Medicine

Ann Arbor, MI
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2. University of Michigan, Department of Surgery, Section of Pediatric Surgery, Ann Arbor, MI
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Corresponding Author:

Meghan A. Arnold, MD
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Section of Pediatric Surgery

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CS Mott Children’s Hospital

1540 E Hospital Drive, SPC4211

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Ann Arbor, MI 48109

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Office: 734-936-8978

Email: meghanar@med.umich.edu

Conflict of Interest: None

Funding: None
 ACCEPTED MANUSCRIPT

Abstract

Infection following surgical procedures leads to increased morbidity and mortality in all populations.

Guidelines to aid providers in the proper use of prophylactic antibiotics exist for adults, but are rare in the

neonatal surgical population. A recent emphasis on appropriate antibiotic stewardship had led to the

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development of more guidelines without a coincident increase in surgical site infection. Robust data from

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randomized, controlled trials, however, remain sparse.

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Keywords

Neonate, surgery, antibiotics, prophylaxis, stewardship

Introduction
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Surgical site infections (SSIs) contribute significantly to overall healthcare costs while increasing the

morbidity and mortality of individual patients.[1-4] The Centers for Disease Control and Prevention (CDC)
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defines surgical site infection as an infection related to an operative procedure that occurs at or near the

surgical incision within 30 or 90 days of the procedure, depending on the type of procedure performed.[5]
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Among surgical patients, SSIs account for 38% of nosocomial infections and occur in 2 to 5% of the more

than 30 million patients undergoing surgical procedures each year.[6]

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Perioperative antibiotic utilization varies significantly and lacks uniformity amongst children’s hospitals.[7]

This is particularly true in the neonatal intensive care unit (NICU) where postnatal and post-procedural
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antibiotics are often administered empirically and without positive cultures demonstrating active

infection.[8] Although neonates are particularly vulnerable to infection due to their immature immune
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system, until recently, there was limited data on perioperative antibiotic prophylaxis and thus there were

no specific guidelines for their use in this age group.[9] With the increased recognition of the deleterious

effects of inappropriate antibiotic use such as the emergence of antibiotic resistant organisms (AROs),

the development of Clostridium difficile colitis and alterations in the microbiota, [10-12] the appropriate
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use of perioperative antibiotics has recently become an active area of investigation and quality

improvement.

There is continued discussion regarding the utilization of preoperative antibiotics in neonates in the

United States. The majority of the current literature on antibiotic prophylaxis has focused on its use in

adult patients. While few protocols exist to help standardize antibiotic utilization in neonates, the concept

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of antibiotic stewardship in this population has recently gained traction and this has led to the

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development of a variety of institutional guidelines. This review aims to provide evidence-based

guidelines for perioperative surgical antibiotic prophylaxis in neonates.

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Although neonates are particularly vulnerable to infection, data suggests that antibiotics are overused in

this population and that significant variability in their use exists. Among California neonatal intensive car

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eunits (NICUs), Schulman et al. demonstrated a 40-fold difference in antibiotic use ranging from 2.4 to

97.1% of patient days.[13] A point prevalence study of 29 NICUs reported that 47% of 827 infants were
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receiving at least one antibiotic on the day of the survey.[14] Given the above trends, it is not surprising

that there has been an emergence of multi-drug resistant gram negative bacilli and invasive candidiasis in
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this population.[15, 16] The prolonged duration of empiric antibiotic therapy for early onset sepsis in

extremely low birth weight infants has also been associated with an increased risk of death and
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necrotizing enterocolitis.[17-19] Other adverse events that may occur with antibiotic use include

nephrotoxicity, hepatotoxicity and hematological abnormalities as well as iatrogenic anemia resulting from
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the serial blood procurement required for therapeutic monitoring.[20] The downstream effects of AROs

include increased morbidity and mortality and increased healthcare costs due to increased virulence,
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delays in appropriate therapy and fewer treatment options as few pharmacokinetic and clinical studies of

antibiotic efficacy are available in the neonatal population.[21, 22] Furthermore, infants infected or
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colonized with AROs may serve as pathogenic reservoirs for other infants and may be a nidus for

potential outbreaks.[23, 24]

The overuse of prophylactic antibiotics in NICUs provides a promising target for the implementation of

antibiotic stewardship guidelines. There are limited data on perioperative antibiotic prophylaxis in this

population and at times the guidelines do not provide specific recommendations for this group.[9] There is
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also consensus that neonates represent a distinct population from adults and that the guidelines designed

for the latter should not be used in the former.[25] The principles for antibiotic stewardship in the NICU

include accurately identifying patients who need antibiotic therapy, using local epidemiology and

resistance patters to guide the selection of empiric therapy, avoiding agents with overlapping activity,

adjusting antibiotics when culture results become available, monitoring drug toxicity, and optimizing the

dose, route and duration of therapy.[26]

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Unique Challenges in Antibiotic Prescribing in the Neonatal Intensive Care Unit

Appropriate antibiotic stewardship in the NICU faces numerous challenges. First, sepsis in infants

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presents with non-specific signs and symptoms that may actually be secondary to non-infectious

processes (e.g. apnea of prematurity or gastroesophageal reflux) which do not require antibiotics therapy.
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Second, procuring adequate amounts of blood for proper culture analysis can be problematic in neonates.

Furthermore, certain blood culture results, such as those indicating the growth of coagulase-negative

staphylococcal (CoNS) species, may prove difficult to distinguish between a true infection, skin
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colonization or sample contamination. Importantly, most neonatal antibiotic treatment is initiated for

suspected rather than proven infection and several studies have shown that antibiotics are overused in
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term and preterm infants.[14-18, 20, 23] For example, in a retrospective review of 754 patients in 2

NICUs, the use of antibiotic therapy was 8.8 fold higher for a presumed infection than for a culture-
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positive infection.[27] In a separate analysis of extremely low birth weight infants, each additional day of

empiric antibiotic use lead to a 7% increase in the odds of NEC and a 16% increase in the odds of
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death.[17] As such, the increasing concern regarding unintended harm from neonatal antibiotic exposure

has energized interest in the general principles of antimicrobial stewardship.[28]

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Developing an Antimicrobial Stewardship Team and Standardizing Antibiotic Prophylaxis in the

NICU

Antibiotic stewardship in neonates is helpful in many ways since it facilitates the proper implementation of

surgical prophylaxis guidelines thereby minimizing inappropriate or prolonged antibiotic therapy. Indeed,
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antibiotic stewardship helps improve patient-specific outcomes and decreases the overall burden of

antimicrobial resistance.[26] Some institutions have performed quality improvement projects in their

NICUs to evaluate antibiotic use and to promote standardized therapeutic guidelines. In January 2016, all

11 NICUs in Oregon and southwest Washington partnered together to create an antibiotic stewardship

collaborative whose goal was to reduce inappropriate antibiotic use in their units. In their first year, this

group was able to reduce antibiotic use by 25%. Strategies used to garner this improvement included

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limiting “rule out sepsis” antibiotic duration to 36 hours and creating “hard stops” in electronic medical

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record ordering systems. Furthermore, utilization of a neonatal early-onset sepsis calculator to better

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define the probability of sepsis based on risk factor assessment also helped guide appropriate antibiotic

therapy.[29] The Vermont Oxford Network (VON) created a quality improvement cohort that demonstrated

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the feasibility of disciplined antibiotic administration. This work was performed in partnership with VON’s

internet-based Newborn Improvement Collaborative for Quality (iNICQ) “Choosing Antibiotics Wisely”, a
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multicenter quality improvement collaborative engaging 167 NICUs (https://public.vtoxford.org/quality-

education/inicq-2018/). Many participating NICUs have published data on the VON website describing

their significant improvements towards overuse and misuse of antibiotics in the neonatal population.
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An example of work that grew out of the VON iNICQ “Choosing Antibiotics Wisely” was a comparison of
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SSI rates pre- and post-implementation of a standardized antibiotic protocol in a level IV tertiary NICU at

the Children’s Hospital of Wisconsin.[8] There were several highlights to this intervention. First, postnatal
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antibiotics were only given if there were signs and symptoms of neonatal infection or if there were

perinatal risk factors for sepsis. Second, if antibiotics were started due to the above, they were to be
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stopped at 48 hours if active infection was not proven by cultures or laboratory values. Third, preoperative

antibiotics consisted of a single, weight-based dose given within 1 hour of incision. Lastly, perioperative
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antibiotics were to be discontinued no later than 72 hours after the procedure. Neonates who underwent a

variety of pediatric surgery procedures were then compared between the pre- and post-implementation

cohorts. A total of 275 neonates were analyzed; 148 pre-protocol and 127 post-protocol. Compliance with

the first 2 recommendations was 97% and resulted in a significant decrease in the median duration of

postnatal antibiotics from 2 days to 0 days (p = 0.001), the number of neonates who were given postnatal

antibiotics (p = 0.01) and the number of neonates who were treated inappropriately, either by duration or
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indication (p = 0.04). Compliance with the second 2 recommendations was 90%. There was no significant

difference in the percentage of neonates who received preoperative antibiotics pre- and post-protocol

(99.3% vs 99.2%; p = 0.91). While the median duration of postoperative antibiotics remained the same at

1 day, the percentage of patients with an inappropriate indication or duration of perioperative antibiotics

decreased from 1.4% to 0% (p = 0.19). Despite a reduction in the overall use of perioperative antibiotics,

there were no differences in (a) SSI rate within 30 days (14% vs 9%; p = 0.21), (b) the development of a

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hospital-acquired infection (13.5% vs 8.7%; p = 0.205), or (c) the development of an infection with a multi-

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drug resistant organism (4.7% vs 1.6%; p = 0.143).[8]

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Taking the concept of antibiotic stewardship one step further, Vu et al. compared the SSI risk in neonates

who received only 24 hours of antibiotics to those who were given a longer course. The overall incidence

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of a surgical site infection was 13% for the 732 operations performed in this study. Using propensity score

matching, the odds of SSI was not different amongst neonates who had received ≤24 hours of antibiotics
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when compared to those receiving >24 hours of antibiotics (OR 1.1; 95% CI 0.6-1.9). This study also

identified several independent predictors of SSI: preoperative infection and reoperation through the same
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incision both within 30 days and later than 30 days.[25]

A similar quality improvement program was completed in a tertiary neonatal unit in the United Kingdom
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where the primary outcome measure was the number of days of antibiotic use per 1000 patient-days.[30]

Over the 14 months of the quality improvement project, over 500 infants were cared for in the unit. The
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antibiotic usage rate (AUR) decreased from a baseline median of 347 per 1000 patient-days prior to

implementation of the program to a median of 198 per 1000 patient-days after its implementation,
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representing a reduction of 43%. From a safety perspective, the implementation of the project did not lead

any critical incidents related to missed or delayed identification and treatment of sepsis. Overall, the
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proportion of infants discharged from the unit never having been exposed to antibiotics increased from

19% prior to implementation to 40% thereafter.[30]

Taken together, these studies suggest that a standardized approach to perioperative antibiotics in

surgical patients in the NICU can be accomplished without an increased risk of surgical site infection.

Translating antibiotic stewardship into daily clinical practice requires diligence, a commitment from all
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stakeholders and an assessment of each institution’s antibiogram. What follows is a brief review of the

literature available for determining optimal antibiotic prophylaxis for a variety of common pediatric surgery

diseases.

Esophageal Atresia With or Without Tracheoesophageal Fistula

In general, antibiotic prophylaxis with amoxicillin/clavulanate has been recommended for neonates with

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esophageal atresia with or without tracheoesophageal fistula (EA/TEF).[31, 32] A single published report

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described the microbial flora present in the proximal pouch in a small population of neonates prior to

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repair. Of those who underwent repair in the first 24 hours of life, 16 of 29 had no organisms isolated from

the proximal pouch. The remaining 13 grew normal oropharyngeal flora regardless of whether prophylaxis

had been administered or not. Eleven neonates who underwent delayed repair were noted to be

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colonized with similar oropharyngeal organisms. Pathologic organisms – Pseudomonas and Serratia –

were only isolated from those who had received prophylaxis.[33] A “debate” on whether antibiotic
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prophylaxis was warranted in this population was recently published. Although both sides focused on the

use of respiratory prophylaxis following repair, [34, 35] there was inadequate evidence to support or
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refute the use of antibiotic prophylaxis in this surgical population.

Laparoscopic Pyloromyotomy
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Laparoscopic pyloromyotomy is one of the most common procedures performed by pediatric surgeons
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and has become the standard approach to treat this condition. While generally considered a clean

operation, prophylactic antibiotics are often administered, perhaps as a hold-over from when the
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procedure was done through an umbilical incision.[36] A recent publication from an academic pediatric

surgery group in Philadelphia took advantage of the observation that while some of their surgeons
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administered perioperative antibiotics prior to laparoscopic pyloromyotomy, others did not.[37] In this

cohort, 57% of infants received antibiotics; cefazolin was given the vast majority of the time (97%). There

were 6 postoperative wound infections – 3 in those who received antibiotics and 3 in those who did not (p

= 0.73). From this limited data it is reasonable to conclude that prophylactic antibiotics are not indicated

prior to laparoscopic pyloromyotomy.

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Colorectal Procedures including Hirschprung Disease

While there is class I evidence in the adult population to support the use of intravenous antibiotic

prophylaxis prior to colorectal procedures, no such data exists in the pediatric population.[38] Significant

variation exists among pediatric surgeons in the use of prophylactic antibiotics prior to colorectal

procedures and prior reports have suggested an increased risk of wound complications if a mechanical

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bowel preparation and/or oral antibiotics were administered preoperatively.[39, 40] A recent publication of

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the American Pediatric Surgical Association Outcomes and Clinical Trials Committee concluded that

mechanical bowel preparation and enteral antibiotic use for elective colorectal surgery could not be

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supported by the available literature. Intravenous antibiotics were recommended prior to colorectal

procedures but were based on adult data and per the adult Surgical Care Improvement Project (SCIP)

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guidelines; doses were adjusted for a pediatric population. [41]

Gastroschisis and Omphalocele

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Little data exists on the appropriate use of antibiotic prophylaxis in the treatment of abdominal wall

defects. While overall survival in gastroschisis approaches 90% and 80% in omphalocele, infectious
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complications are relatively common and may occur in up to 25% of neonates who undergo primary

closure.[42-44] However, these results were generated from case series and more robust data is needed
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before data-based recommendations can be made.

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Although significant variations in the use of the prophylactic antibiotics in the neonatal surgical population

exist, general recommendations can be made based on the data available. Table 1 summarizes the
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generally accepted antibiotic prophylaxis guidelines for neonates according to the type of surgical

procedure performed.
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Conclusion

Significant practice variation exists among neonatologists and pediatric surgeons regarding perioperative

antibiotic utilization in neonates. As a whole, these studies and quality improvement projects suggest that

a standardized approach to perioperative antibiotic use in surgical neonates can be accomplished without

an increased risk of surgical site infection or other morbidity. Implementation of an antibiotic stewardship
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protocol can create an opportunity to build and sustain effective collaboration between neonatologists and

surgeons and in doing so avoid the negative sequelae of antibiotic overuse in this population.

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_GEN_136_CHI_053.pdf.
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Table 1. Perioperative antibiotic prophylaxis (Adapted from [45])

Type of Case Examples Antibiotics

CVC/Broviac/Port

Bronchoscopy

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Circumcision

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Clean Inguinal hernia None

Neonatal testicular torsion

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Ovarian cyst

Gastroschisis/Omphalocele

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Biliary tract/Choledochal cyst

Congenital diaphragmatic hernia

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Duodenal atresia

Clean-Contaminated Gastrostomy tube Cefazolin x1 dose

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Nissen fundoplication

Liver biopsy
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Head and neck surgery

Jejunal/ileal atresia
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EA/TEF Cefazolin/Flagyl
x24-48
Contaminated Hirschprung disease pullthrough Piperacillin/tazobactam
hours
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Ostomy closure Cefoxitin

PSARP
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