Neonatal Drug Therapy Manual

Probiotics (Flora Baby)

Disclaimer: Official controlled document is the CHEO and Ottawa Hospital online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Lactobacillus rhamnosus, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium infantis, Bifidobacterium longum
Probiotics supplement
Original Date: 
June 2015
Revised Date: 
September 2019
  • Prevention of severe Necrotizing Enterocolitis (NEC) and mortality in all infants born at < 33+6 weeks gestational age or < 1500 g
  • PO
    • Each dose should be mixed in 1 mL of sterile water just prior to administration
  • 0.5 g of powder by NG tube/mouth once a day before feeding
  • Start as early as possible, when neonate is clinically stable and ready to receive enteral feeds.
  • Discontinue when neonate reaches 34 weeks corrected age or is transferred to a neonatal unit not using probiotics.
Side Effects: 
  • Usually well tolerated
Parameters to Monitor: 
  • Gastro-intestinal tolerance
Reconstitution and Stability: 
  • Keep refrigerated


  • Contraindications:
    • Absolute:
      • Patient is NPO
      • Innate immune deficiency
      • No realistic prospect of survival
    • Relative:
      • Neonatal asphyxia
      • History of grade 3 NEC, intestinal perforation or recent intestinal surgery
      • Congenital anomaly of the digestive tract
      • Any medical condition where the integrity of the digestive tract is compromised (ex: suspected or proven CMPA, sepsis, hemodynamically significant PDA). (Probiotics can be held at the discretion of the attending physician during an episode of sepsis or in the presence of an active PDA, until clinical stability is reached)
      • Acquired immunodeficiency (ex: after treatment with moderate to high dose steroids for more than 2 weeks)

- W Yee & The Canadian Neonatal Network: "Incidence and Timing of Presentation of Necrotizing Enterocolitis in Preterm Infants".  Pediatrics 2012

- Canadian Neonatal Network, Annual Report 2012

- AlFaleh KM, Bassler D: " Probiotics for prevention of necrotizing enterocolitis in preterm infants (Review)". Cochrane 2014

- Janvier & Al: "Cohort Study of Probiotics in a North American Neonatal Intensive Care Unit".  The Journal of Pediatrics 2014

- Parker R: Probiotic Guideline for necrotizing Enterocolitis Prevention in Very Low0Birth-Weight Neonates. Advances in Neonatal Care, (2014) Vol 14, No 2, pp88-95

- Deshpande, G.C., Rao, S.C.., Keil A.D., Patole, S.K. Evidence-based guidelines for use of probiotics in preterm neonates.  BMC Medicine 2011, 9:92

- Deshpande, G et al. Updated Meta-analysis of Probiotics for  Preventing Necrotizing Enterocolitis in Preterm Neonates. Pediatrics 2010;125;921; DOI:10.1542/peds. 2009-1301


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