PMID- 32846100
OWN - NLM
STAT- MEDLINE
DCOM- 20210827
LR  - 20210827
IS  - 1208-6002 (Electronic)
IS  - 0829-8211 (Linking)
VI  - 99
IP  - 1
DP  - 2021 Feb
TI  - Dose escalation study of bovine lactoferrin in preterm infants: getting the dose 
      right.
PG  - 7-13
LID - 10.1139/bcb-2020-0217 [doi]
AB  - Lactoferrin as a nutritional enteral supplement has emerged as a novel 
      preventative therapy against serious infections in preterm infants, although 
      neonatal studies have demonstrated variable results, in part due to the lack of 
      pharmacokinetic data and differences in the products tested. We conducted a 
      prospective, dose escalation (100, 200, and 300 mg.kg(-1).day(-1)) safety study 
      of bovine lactoferrin (Glanbia Nutritionals, USA) dissolved in sterile water (100 
      mg.mL(-1)) for 30 days in preterm infants with birth weight <1500 g. Safety 
      related to adverse events (AEs), tolerability, and exposure-response of 
      lactoferrin was assessed. We enrolled 31 patients [10, 10, and 11 patients, for 
      the lactoferrin treatment groups (100, 200, and 300 mg.kg(-1).day(-1), 
      respectively)] over a 10-month period. No AEs related to the study solution 
      occurred, and lactoferrin was tolerated by each group. During lactoferrin 
      supplementation, one bloodstream infection occurred in each group, but there were 
      no incidences of urinary tract infections and no cases of necrotizing 
      enterocolitis. Postnatal cytomegalovirus acquisition was detected in the group 
      treated with 200 mg.kg(-1).day(-1) (n = 2). There were no adverse effects on 
      hepatic, renal, or hematologic function. All of the patients survived to 
      discharge. Bovine lactoferrin at doses up to 300 mg.kg(-1).day(-1) is safe in 
      preterm infants. Future studies examining higher doses of lactoferrin, length of 
      treatment, and potency of different products will aid in determining the optimal 
      approach for the use of lactoferrin to prevent infections in preterm infants.
FAU - Kaufman, David A
AU  - Kaufman DA
AD  - Department of Pediatrics, University of Virginia, Charlottesville, Virginia, USA.
FAU - Berenz, Andrew
AU  - Berenz A
AD  - Department of Pediatrics, Rush University Medical Center, Chicago, Illinois, USA.
FAU - Itell, Hannah L
AU  - Itell HL
AD  - Department of Molecular and Cellular Biology, University of Washington, 
      Washington, USA.
FAU - Conaway, Mark
AU  - Conaway M
AD  - Department of Biostatistics, University of Virginia, Charlottesville, Virginia, 
      USA.
FAU - Blackman, Amy
AU  - Blackman A
AD  - Department of Pediatrics, University of Virginia, Charlottesville, Virginia, USA.
FAU - Nataro, James P
AU  - Nataro JP
AD  - Department of Pediatrics, University of Virginia, Charlottesville, Virginia, USA.
FAU - Permar, Sallie R
AU  - Permar SR
AD  - Duke Human Vaccine Institute, Duke University Medical Center, Durham, North 
      Carolina, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200826
PL  - Canada
TA  - Biochem Cell Biol
JT  - Biochemistry and cell biology = Biochimie et biologie cellulaire
JID - 8606068
RN  - EC 3.4.21.- (Lactoferrin)
SB  - IM
MH  - Animals
MH  - Birth Weight
MH  - Cattle
MH  - Dietary Supplements
MH  - Enterocolitis, Necrotizing/prevention & control
MH  - Humans
MH  - Infant, Newborn
MH  - Infant, Premature
MH  - Lactoferrin/*administration & dosage
MH  - Prospective Studies
MH  - Urinary Tract Infections/prevention & control
OTO - NOTNLM
OT  - infection prevention
OT  - innocuite
OT  - lactoferrin
OT  - lactoferrine
OT  - nourrissons prematures
OT  - preterm infants
OT  - prevention des infections
OT  - safety
EDAT- 2020/08/28 06:00
MHDA- 2021/08/28 06:00
CRDT- 2020/08/27 06:00
PHST- 2020/08/28 06:00 [pubmed]
PHST- 2021/08/28 06:00 [medline]
PHST- 2020/08/27 06:00 [entrez]
AID - 10.1139/bcb-2020-0217 [doi]
PST - ppublish
SO  - Biochem Cell Biol. 2021 Feb;99(1):7-13. doi: 10.1139/bcb-2020-0217. Epub 2020 Aug 
      26.