TY - JOUR
T1 - Effect of bovine lactoferrin on prevention of late-onset sepsis in infants: a pooled analysis of individual patient data from two randomized controlled trials
AU - Ochoa, Theresa J
AU - Loli, Sebastian
AU - Mendoza, Karina
AU - Carcamo, Cesar
AU - Bellomo, Sicilia
AU - Cam, Luis
AU - Castañeda, Anne
AU - Campos, Miguel
AU - Jacobs, Jan
AU - Cossey, Veerle
AU - Zegarra, Jaime
N1 - CPDF
PY - 2020
Y1 - 2020
N2 - We previously conducted two randomized controlled trials of bovine lactoferrin (bLF) for prevention of late-onset sepsis (LOS) in infants with a birth weight <2500g (Study 1) and <2000g (Study 2). The aim of this study was to determine the effect of bLF on prevention of culture-proven or probable LOS in infants with a birth weight <1500g from both studies, and to determine the bLF effect depending on human milk intake. Both trial designs had similar inclusion and exclusion criteria, same bLF dose (200mg/kg/day) and same control (maltodextrin). We fitted multivariate Cox regression models to estimate the effect of bLF on the risk of development of the composite outcome, adjusting for covariates. We included 335 neonates with a mean birth weight of 1162g ±244g; 27.5% were <1000g. There were 33 first episodes of LOS in the bLF group and 48 in the control group (19.5% vs 28.9%). bLF had a protective effect on the risk of development LOS, Hazard Ratio (HR) 0.64 (%95CI: 0.41-0.99,p=0.048); particularly among infants <1000g, HR 0.46 (%95CI: 0.22-0.96,p=0.039) and among infants with low human milk intake, HR 0.40 (%95CI: 0.19-0.84,p=0.015). bLF supplementation protects against LOS in infants <1500g, especially among infants not receiving human milk.
AB - We previously conducted two randomized controlled trials of bovine lactoferrin (bLF) for prevention of late-onset sepsis (LOS) in infants with a birth weight <2500g (Study 1) and <2000g (Study 2). The aim of this study was to determine the effect of bLF on prevention of culture-proven or probable LOS in infants with a birth weight <1500g from both studies, and to determine the bLF effect depending on human milk intake. Both trial designs had similar inclusion and exclusion criteria, same bLF dose (200mg/kg/day) and same control (maltodextrin). We fitted multivariate Cox regression models to estimate the effect of bLF on the risk of development of the composite outcome, adjusting for covariates. We included 335 neonates with a mean birth weight of 1162g ±244g; 27.5% were <1000g. There were 33 first episodes of LOS in the bLF group and 48 in the control group (19.5% vs 28.9%). bLF had a protective effect on the risk of development LOS, Hazard Ratio (HR) 0.64 (%95CI: 0.41-0.99,p=0.048); particularly among infants <1000g, HR 0.46 (%95CI: 0.22-0.96,p=0.039) and among infants with low human milk intake, HR 0.40 (%95CI: 0.19-0.84,p=0.015). bLF supplementation protects against LOS in infants <1500g, especially among infants not receiving human milk.
U2 - 10.1139/bcb-2020-0046
DO - 10.1139/bcb-2020-0046
M3 - A1: Web of Science-article
C2 - 32931708
JO - Biochemistry and Cell Biology = Biochimie et Biologie Cellulaire
JF - Biochemistry and Cell Biology = Biochimie et Biologie Cellulaire
SN - 0829-8211
ER -