Is Lactoferrin More Effective in Reducing Late-Onset Sepsis in Preterm Neonates Fed Formula Than in Those Receiving Mother's Own Milk? Secondary Analyses of Two Multicenter Randomized Controlled Trials

Paolo Manzoni, Maria Angela Militello, Stefano Rizzollo, Elena Tavella, Alessandro Messina, Marta Pieretto, Elena Boano, Martina Carlino, Eleonora Tognato, Roberta Spola, Anna Perona, Milena Maria Maule, Ruben García Sánchez, Mike Meyer, Ilaria Stolfi, Lorenza Pugni, Hubert Messner, Silvia Cattani, Pasqua Maria Betta, Luigi MemoLidia Decembrino, Lina Bollani, Matteo Rinaldi, Maria Fioretti, Michele Quercia, Chryssoula Tzialla, Nicola Laforgia, Fabio Mosca, Rosario Magaldi, Michael Mostert, Daniele Farina, William Tarnow-Mordi, Italian Task Force for the Study Prevention of Neonatal Fungal Infections; the Italian Society of Neonatology

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Abstract

BACKGROUND: Lactoferrin is the major antimicrobial protein in human milk. In our randomized controlled trial (RCT) of bovine lactoferrin (BLF) supplementation in preterm neonates, BLF reduced late-onset sepsis (LOS). Mother's own milk (MM) contains higher concentrations of lactoferrin than donor milk or formula, but whether BLF is more effective in infants who receive formula or donor milk is uncertain. AIM: To evaluate the incidence of LOS in preterm infants fed MM and in those fed formula and/or donor milk. STUDY DESIGN: This is a (A) post hoc subgroup analysis, in our RCT of BLF, of its effects in preterm infants fed MM, with or without formula, versus those fed formula and/or donor milk (no-MM) and (B) post hoc meta-analysis, in our RCT of BLF and in the ELFIN (Enteral Lactoferrin in Neonates) RCT, of the effect of BLF in subgroups not exclusively fed MM. RESULTS: (A) Of 472 infants in our RCT, 168 were randomized to placebo and 304 were randomized to BLF. Among MM infants, LOS occurred in 22/133 (16.5%) infants randomized to placebo and in 14/250 (5.6%) randomized to BLF (relative risk or risk ratio (RR): 0.34; relative risk reduction (RRR): 0.66; 95% confidence interval (95% CI) for RR: 0.18-0.64; p 
Original languageEnglish
Pages (from-to)S120-S125
JournalAmerican Journal of Perinatology
Volume36
Issue numberS 02
DOIs
Publication statusPublished - Jul 2019

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