Implementation of a probiotic protocol to reduce rates of necrotizing enterocolitis

Abstract

Objective

To utilize a probiotic protocol to achieve a 50% reduction in rates of necrotizing enterocolitis (NEC) ≥ Bell Stage 2 within 2 years of protocol implementation.

Study design

Literature review guided probiotic selection and protocol design. A driver diagram identified key drivers to achieve our aim. A U chart followed monthly NEC ≥ Bell Stage 2 per 100 patient days and per monthly admissions. The process measure was protocol compliance and the balancing measure was probiotic sepsis.

Results

NEC ≥ Bell Stage 2 decreased from 0.14 to 0.04 per 100 patient days in infants < 33 weeks gestation or <1500 g, or a yearly rate of 7–2%. Protocol compliance was 98% and there were no cases of probiotic sepsis.

Conclusion

Implementation of a probiotic protocol was associated with a decrease in rates of NEC.

Access optionsAccess options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

Fig. 1
Fig. 2
Fig. 3

References

  1. 1.

    Neu J, Walker WA. Necrotizing enterocolitis. N Engl J Med. 2011;364:255–64.

  2. 2.

    Nino DF, Sodhi CP, Hackam DJ. Necrotizing enterocolitis: new insights into pathogenesis and mechanisms. Nat Rev Gastroenterol Hepatol. 2016;13:590–600.

  3. 3.

    Hackam DJ, Sodhi CP, Good M. New insights into necrotizing enterocolitis: from laboratory observation to personalized prevention and treatment. J Pediatr Surg. 2018. https://doi.org/10.1016/j.jpedsurg.2018.06.012.

  4. 4.

    Sekhon MK, Yoder BA. Impact of umbilical cord milking and pasteurized donor human milk on necrotizing enterocolitis: a retrospective review. BMC Pediatr. 2018;8:155. https://doi.org/10.1186/s12887-018-1131-x.

  5. 5.

    Pammi M, Cope J, Tarr PI, Warner BB, Morrow AL, Mai V, et al. Intestinal dysbiosis in preterm infants preceding necrotizing enterocolitis: a systematic review and meta-analysis. Microbiome. 2017;5. https://doi.org/10.1186/s40168-017-0248-8.

  6. 6.

    Warner BB, Deych E, Zhou Y, Hall-Moore C, Weinstock GM, Sodergren E, et al. Gut bacteria dysbiosis and necrotizing enterocolitis in very low birth weight infants: a prospective case-control study. Lancet 2016;387:1928–36.

  7. 7.

    Patel RM, Underwood MA. Probiotics and necrotizing enterocolitis. Semin Pediatr Surg. 2018;27:39–46.

  8. 8.

    Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, et al. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotics. Nat Rev Gastroenterol Hepatol. 2014;11:506–14.

  9. 9.

    Thomas JP, Raine T, Reddy S, Belteki G. Probiotics for the prevention of necrotizing enterocolitis in very low birth weight infants: a meta-analysis and systemic review. Acta Paediatr. 2017;106:1729–41.

  10. 10.

    AlFaleh K, Anabrees J. Probiotics for prevention of necrotizing enterocolitis in preterm infants (Review). Cochrane Database Syst Rev. 2014. https://doi.org/10.1002/14651858.CD005496.pub4.

  11. 11.

    Patel S, Clark EAS, Rodriguez C, Metz TD, Abbaszadeh M, Yoder BA. Effect of umbilical cord milking on morbidity and survival in extremely low gestational age neonates. Am J Obstet Gynecol. 2014;211:519e1–7.

  12. 12.

    Janvier A, Malo J, Barrington KJ. Cohort study of probiotics in a North American neonatal intensive care unit. J Pedia. 2014;164:980–5.

  13. 13.

    Singh B, Shah PS, Afifi J, Simpson CD, Mitra S, Dow K, et al. Probiotics for preterm infants: a national retrospective cohort study. J Perinatol. 2019;39:533–9.

  14. 14.

    Government of Canada. Health Canada. About natural health product regulation in Canada. 2016. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/regulation.html. Accessed Jan 1 2019.

  15. 15.

    Kliegman RM, Walsh MC. Neonatal necrotizing enterocolitis: pathogenesis, classification, and spectrum of illness. Curr Probl Pedia. 1987;17:213–88.

  16. 16.

    Pumberger W, Mayr M, Kohlhauser C, Weninger M. Spontaneous localized intestinal perforation in very-low-birth-weight infants: a distinct clinical entity different from necrotizing enterocolitis. J Am Coll Surg. 2002;195:796–803.

  17. 17.

    Nathan AT, Ward L, Schibler K, Moyer L, South A, Kaplan HC. A quality improvement initiative to reduce necrotizing enterocolitis across hospital systems. J Perinatol. 2018;38:742–50.

  18. 18.

    Benneyan JC, Lloyd RC, Plsek PE. Statistical process control as a tool for research and healthcare improvement. Qual Saf Health Care. 2003;12:458–64.

  19. 19.

    Montgomery DC. Introduction to statistical quality control. 6th ed. Jefferson City: John Wiley & Sons, Inc; 2009.

  20. 20.

    Laney DB. Improved control charts for attributes. Qual Eng. 2002;14:531–7.

  21. 21.

    Kunz AN, Noel JM, Fairchok MP. Two cases of Lactobacillus bacteremia during probiotic treatment of short gut syndrome. J Pediatr Gastroenterol Nutr. 2004;38:457–8.

  22. 22.

    Zbinden A, Zbinden R, Berger C, Arlettaz R. Case series of Bifidobacterium longum bacteremia in three preterm infants on probiotic therapy. Neonatology. 2015;107:56–59.

  23. 23.

    Dani C, Coviello C, Corsini I, Arena F, Antonelli A, Rossolini GM. Lactobacillus sepsis and probiotic therapy in newborns: to new cases and literature review. Am J Perinatol Rep. 2016;6:e25–9.

  24. 24.

    Ohishi A, Takahashi S, Ito Y, Ohishi Y, Tsukamoto K, Nanba Y, et al. Bifidobacterium septicemia associated with postoperative probiotic therapy in a neonate with omphalocele. J Pediatr. 2010;156:679–81.

  25. 25.

    Hand MH, Rouster-Stevens K, Woods CR, Cannon ML, Cnota J, Shetty AK. Lactobacillus sepsis associated with probiotic therapy. Pediatrics. 2005;115:178–81.

  26. 26.

    Vallabhaneni S, Walker TA, Lockhart SR, Ng D, Chiller T, Melchreit R, et al. Fatal gastrointestinal mucormycosis in a premature infant associated with a contaminated dietary supplement—Connecticut 2014. Morb Mortal Wkly Rep. 2015;64:155–6.

  27. 27.

    Lin HC, Hsu CH, Chen HL, Chung MY, Hsu JF, Lien RI, et al. Oral probiotics prevent NEC in VLBW preterm infants: a multicenter RCT. Pediatrics. 2008;122:693–700.

  28. 28.

    Bin-nun A, Bromiker R, Wilschanski M, Kaplan M, Rudensky B, Hammerman C. Oral Probiotics prevent necrotizing enterocolitis in very low birth weight neonates. J Pediatr. 2005;147:192–6.

  29. 29.

    Jacobs SE, Tobin JM, Opie GF, Donath S, Tabrizi SN, Pirotta M, et al. Probiotic effects on late onset sepsis in very preterm infants: a randomized controlled trial. Pediatrics. 2013;132:1055–62.

  30. 30.

    Sari FN, Dizdar EA, Oguz S, Erdeve O, Uras N, Dilmen U. Oral probiotics: lactobacillus sporogenes for prevention of necrotizing enterocolitis in VLBW infants: an RCT. Eur J Clin Nutr. 2011;65:434–39.

  31. 31.

    Costeloe K, Hardy P, Juszczak E, Wilks M, Millar MR, The Probiotics in Preterm Infants Study Collaborative Group. Bifidobacterium breve BBG-001 in very preterm infants: a randomized controlled phase 3 trial. Lancet. 2016;387:649–60.

  32. 32.

    Sawh SC, Deshpande S, Jansen S, Reynaert CJ, Jones PM. Prevention of necrotizing enterocolitis with probiotics: a systematic review and meta-analysis. PeerJ. 2016;4:e2429. https://doi.org/10.7717/peerj.2429

  33. 33.

    Boundy EO, Perrine CG, Nelson JM, Hamner HC. Disparities in hospital-reported breast milk use in neonatal intensive care units—United States, 2015. Morb Mortal Wkly Rep. 2017;66:1313–7.

  34. 34.

    Mohamed MA, El-Dib M, Alqahtani S, Alyami K, Ibrahim AN, Aly H. Patent ductus arteriosus in premature infants: to treat or not to treat? J Perinatol. 2017;27:625–57.

  35. 35.

    Roze JC, Cambonie G, Marchand-Martin L, Gournay V, Durrmeyer X, Durox M, et al. Association between early screening for patent ductus arteriosus and in-hospital mortality among extremely preterm infants. JAMA. 2015;313:2441–8.

  36. 36.

    Mitra S, Florez ID, Tamayo ME, Mbuagbaw L, Vanniyasingam T, Veroniki AA, et al. Association of placebo, indomethacin, ibuprofen, and acetaminophen with closure of hemodynamically significant patent ductus arteriosus in preterm infants: a systematic review and meta-analysis. JAMA. 2018;319:1221–38.

  37. 37.

    Gephart SM, Gordon PV, Penn AH, Gregory KE, Swanson JR, Maheshwari A, et al. Changing the paradigm of defining, detecting, and diagnosing NEC: perspectives on Bell’s stages and biomarkers for NEC. Semin Pediatr Surg. 2018;27:3–10.

  38. 38.

    Huang CH, Li SW, Huang L, Watanabe K. Identification and classification for the Lactobacillus casei group. Front Microbiol. 2018;9:1974. https://doi.org/10.3389/fmicb.2018.01974

Download references

Author contributions

MKS was involved in probiotic protocol implementation, compliance tracking, data collection and analysis, and manuscript preparation. PHG assisted in data analysis and manuscript revision. MN was involved in data extraction from the EMR. BAY developed the probiotic protocol, monitored compliance, and reviewed the manuscript.

Author information

Correspondence to Mehtab K. Sekhon.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Additional information

Publisher’s note: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary information

Supplementary table 1

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark