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Identifying the Incidence of Culture-Driven Infection After the Use of Probiotics in Neonates at a Level III Neonatal Intensive Care Unit
Thursday April 24, 2025 11:00am - 11:15am EDT
Athena J
Objective: 
Investigate the incidence of culture-proven infection in pre-term and VLBW and low birth weight (LBW) neonates in the NICU at USACWH
 
Self-Assessment Question: 
What probiotic had the greatest incidence of positive cultures? A. Culturelle B. UP4 C. Ultimate Flora Baby


Background: 
Pre-term neonates have an immature gut barrier and alterations in the microbiota increase their risk for morbidity and mortality. Probiotics are used to colonize the gastrointestinal tract with beneficial microorganisms to prevent complications such as necrotizing enterocolitis (NEC) and colonization of Clostridium difficile. Currently, the American Gastroenterological Association (AGA) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) guidelines recommend probiotics in pre-term and low-birth weight neonates to prevent NEC in the hospitalized setting. A risk factor of probiotics in this patient population is the translocation of a probiotic species across their permeable barrier and out of the digestive tract.  The University of South Alabama Children’s and Women’s Hospital (USACWH) used probiotics liberally in the neonatal intensive care unit (NICU) until the fall of 2023. Probiotic use ceased after the U.S Food and Drug Administration (FDA) issued a healthcare warning on probiotic use in hospitalized pre-term or very low birth weight (VLBW) infants due to the potential risk of invasive and potentially fatal disease from live bacteria or yeast.   This study aims to investigate the incidence of culture-proven infection in pre-term and VLBW and low birth weight (LBW) neonates in the NICU at USACWH.
 
Methods: 
This is a single-site, retrospective review of neonates admitted to a level III NICU between 2017 and 2024.  The primary outcome was the incidence of positive cultures matching a probiotic species in preterm or VLBW and LBW infants. Pre-term neonates between 21 weeks to 38 weeks gestational age or LBW defined as < 2,500 grams, received > 72 hours of probiotics, and a positive culture matching the probiotic species were included. Patients were excluded if they were > 38 weeks gestational age, weighed > 2,500 grams, or received < 72 hours of probiotics. The key secondary data points include past medical history, type of probiotic, day of admission probiotics were initiated, duration of probiotic, type of culture, culture speciation, ICD-10 code for NEC, and cause of death.   Statistical tests used were means and standard deviations for descriptive statistics, Naranjo criteria, means and standard deviations.
 
Results:  
A total of 871 patients received probiotics. There was a total of 6 neonates with positive cultures matching the probiotic species. This correlates with an incidence rate of 0.69 new positive culture for every 100 patients.  All 6 neonates with positive cultures received Ultimate Flora Baby (UFB), containing Bifidobacterium spp (B. infantis, B. breve, B. longum, B. rhamnoses, B. acidophilus) and Lactobacillus spp (L. rhamnoses, L. acidophilus). Out of the 871 patients, 726 (83%) patients received UFB, 133 (15%) patients received UP4, and 12 (2%) patients received Culturelle.  A Naranjo score of 6 suggests the positive blood cultures were a probable adverse event from the probiotic. However, other factors might have contributed to the positive cultures. The results of the possible factors that may have contributed to the positive cultures are still pending.  
 
Conclusion: 
Among preterm, VLBW, and LBW infants receiving probiotics in the NICU at USACWH there was a low incidence rate of positive blood cultures.  Factors that could have contributed to the positive cultures is still in progress.  


Moderators
avatar for Justin Chen

Justin Chen

Pharmacist Specialist, Children's Healthcare of Atlanta
Solid Organ Transplant Pharmacist Specialist at Children's Healthcare of Atlanta. Residency Program Coordinator for the PGY2 program.
Presenters
avatar for Angelique Holmes

Angelique Holmes

PGY-1 Pharmacy Resident, USA Health University Hospital
 Angelique Holmes is a PGY-1 pharmacy resident at USA Health University Hospital and a proud native of Michigan. She earned her Bachelor of Science degree from Western Michigan University and attended Auburn University's Harrison College of Pharmacy, where she graduated with honors... Read More →
Evaluators
AH
Thursday April 24, 2025 11:00am - 11:15am EDT
Athena J
  Pediatric (PED), USA Health University Hospital
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