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 - PPU; NOOA
PY - 2021
Y1 - 2021
N2 - We previously conducted two randomized controlled trials with bovine lactoferrin (bLF) for the prevention of late-onset sepsis (LOS) in infants with a birth weight <2500 g (Study 1) and <2000 g (Study 2). The aim of this study was to determine the preventative effects of bLF on culture-proven or probable LOS in infants with a birth weight <1500 g from both studies, and to determine the effect of bLF in relation to intake of human milk. Both trial designs had similar inclusion and exclusion criteria, the same dose of bLF [200 mg·(kg body mass)
-1·day
-1], and used the 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 1162 ± 244 g; 27.5% were <1000 g. There were 33 first episodes of LOS in the bLF treatment group and 48 in the control group (19.5% vs. 28.9%). bLF had a protective effect on the risk of development of LOS [hazard ratio (HR) = 0.64; %95 CI = 0.41-0.99;
p = 0.048]; particularly among infants weighing <1000 g [HR = 0.46; %95 CI = 0.22-0.96;
p = 0.039] and infants with a low intake of human milk [HR = 0.40; %95 CI = 0.19-0.84;
p = 0.015]. Therefore, bLF supplementation protects infants <1500 g from LOS, particularly those infants not receiving human milk.
AB - We previously conducted two randomized controlled trials with bovine lactoferrin (bLF) for the prevention of late-onset sepsis (LOS) in infants with a birth weight <2500 g (Study 1) and <2000 g (Study 2). The aim of this study was to determine the preventative effects of bLF on culture-proven or probable LOS in infants with a birth weight <1500 g from both studies, and to determine the effect of bLF in relation to intake of human milk. Both trial designs had similar inclusion and exclusion criteria, the same dose of bLF [200 mg·(kg body mass)
-1·day
-1], and used the 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 1162 ± 244 g; 27.5% were <1000 g. There were 33 first episodes of LOS in the bLF treatment group and 48 in the control group (19.5% vs. 28.9%). bLF had a protective effect on the risk of development of LOS [hazard ratio (HR) = 0.64; %95 CI = 0.41-0.99;
p = 0.048]; particularly among infants weighing <1000 g [HR = 0.46; %95 CI = 0.22-0.96;
p = 0.039] and infants with a low intake of human milk [HR = 0.40; %95 CI = 0.19-0.84;
p = 0.015]. Therefore, bLF supplementation protects infants <1500 g from LOS, particularly those 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
VL - 99
SP - 14
EP - 19
JO - Biochemistry and Cell Biology = Biochimie et Biologie Cellulaire
JF - Biochemistry and Cell Biology = Biochimie et Biologie Cellulaire
SN - 0829-8211
IS - 1
ER -