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Effect of lactoferrin in the prevention of late-onset sepsis in preterm neonates: a randomized-controlled trial

Background Lactoferrin (LTF) is a promising drug in the prevention of late-onset sepsis (LOS) in preterm infants as it causes priming of the immune system before the occurrence of insult. Aim The aim of this study is to evaluate the effect of LTF in the prevention of LOS. Participants and methods Preterm infants of gestational age less than or equal to 34 weeks showing no signs of sepsis in the first 72 h and admitted to NICU of Alexandria University Children Hospital from August 2019 to April 2020 were included in this study. Fifty six patients were randomly allocated into two groups: LTF group (n=28 patients) and control group (n=28 patients). Patients in the LTF group received LTF for 28 days postnatally or till 36 weeks postmenstrual age, whichever is reached first. All patients were monitored for development of LOS. Results Compared with the control group, LTF treatment was associated with a significantly lower incidence of culture-proven LOS (8/28 vs. 2/28, respectively) with a P value of 0.036. The administration of LTF decreased the serum C-reactive protein level at the end of the study in comparison with the level at the beginning of the study in the LTF group, with a mean value of 5.44±16.18 versus 3.71±2.57, respectively (P=0.021), and in comparison with the control group, with a mean value of 5.44±16.18 versus 27.45±55.20, respectively (P=0.021). Conclusion LTF reduces the incidence of culture-proven LOS in preterm neonates aged less than or equal to 34 weeks. LTF has been proven to have anti-inflammatory properties through its ability to decrease the C-reactive protein level.