EFFECT OF ADMINISTRATION OF COMBINED ENTERAL LACTOFERRIN AND PROBIOTIC ON INVASIVE FUNGAL INFECTIONS IN PRETERM

Document Type : Original Article

Abstract

Background: Invasive fungal infections (IFI) are responsible for late-onset sepsis in neonates especially preterm, with significant morbidity and mortality. Oral bovine lactoferrin (LF) alone or with probiotics has several potentially significant health benefits and immunomodulation.
Objectives: to evaluate efficacy and safety of enterally administered bovine LF alone or in combination with probiotics in prevention of IFI in preterm in comparison to placebo.
Patients and Methods: This study is registered in clinicalTrials.gov (ClinicalTrials.gov Identifier: NCT05283278). A prospective double blinded study conducted on 80 preterm, randomly received LF (100 mg/day) (n=20), LF + (LF 100 mg/day plus probiotics 109–1010 colony forming unit) (n=20), or placebo (n=40) for 4 weeks. Blood culture for fungal infection was done at enrollment, days 7, 14, 21 and 28.
Results: There was no significant difference between LF and LF+ vs placebo as regards the initial CBC and CRP. Then, placebo showed significantly more clinical signs of sepsis vs LF and vs LF+ (P = 0.003 and 0.001, respectively). Rate of increase of milk intake (mean ±SD) was higher in both LF (18.75 ± 6.04) and LF+ (19.2 ± 6.6) vs placebo (14.00 ± 4.76) (ml/kg/day), (p = 0.0015 and p= 0.0009, respectively); and time to reach full enteral feeding (days) was shorter in both LF and LF+ vs placebo; (10.95± 4.72) and (7.4 ± 1.98) vs (14.67 ±6.61), (p = 0.03 and p < 0.001 respectively). Both LF and LF+ had less packed red blood cell (PRBC) transfusion than placebo, but only LF vs placebo reached statistical significance (P = 0.05). No reported deaths in either LF or LF+, however, placebo had 25 % deaths (P = 0.017 each). Placebo had the longest hospital stay (29.55 ± 9.87) days vs (23 ± 9.52) and (15.1 ± 2.94) in LF and LF+, respectively (P = 0.0173 and 0,0001 respectively). Placebo had significantly more fungal infection vs LF and LF+ groups (P = 0.0001 each) mainly Candida albicans followed by Candida tropicalis.
Conclusion: Prophylactic enteral administration of LF either alone or in combination with probiotic reduces IFI, increased hemoglobin concentration, decrease blood transfusion, LOS, and mortality in preterm.

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