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Dose escalation study of bovine lactoferrin in preterm infants: getting the dose right.

Publication ,  Journal Article
Kaufman, DA; Berenz, A; Itell, HL; Conaway, M; Blackman, A; Nataro, JP; Permar, SR
Published in: Biochem Cell Biol
February 2021

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.

Duke Scholars

Published In

Biochem Cell Biol

DOI

EISSN

1208-6002

Publication Date

February 2021

Volume

99

Issue

1

Start / End Page

7 / 13

Location

Canada

Related Subject Headings

  • Urinary Tract Infections
  • Prospective Studies
  • Lactoferrin
  • Infant, Premature
  • Infant, Newborn
  • Humans
  • Enterocolitis, Necrotizing
  • Dietary Supplements
  • Cattle
  • Birth Weight
 

Citation

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Kaufman, D. A., Berenz, A., Itell, H. L., Conaway, M., Blackman, A., Nataro, J. P., & Permar, S. R. (2021). Dose escalation study of bovine lactoferrin in preterm infants: getting the dose right. Biochem Cell Biol, 99(1), 7–13. https://doi.org/10.1139/bcb-2020-0217
Kaufman, David A., Andrew Berenz, Hannah L. Itell, Mark Conaway, Amy Blackman, James P. Nataro, and Sallie R. Permar. “Dose escalation study of bovine lactoferrin in preterm infants: getting the dose right.Biochem Cell Biol 99, no. 1 (February 2021): 7–13. https://doi.org/10.1139/bcb-2020-0217.
Kaufman DA, Berenz A, Itell HL, Conaway M, Blackman A, Nataro JP, et al. Dose escalation study of bovine lactoferrin in preterm infants: getting the dose right. Biochem Cell Biol. 2021 Feb;99(1):7–13.
Kaufman, David A., et al. “Dose escalation study of bovine lactoferrin in preterm infants: getting the dose right.Biochem Cell Biol, vol. 99, no. 1, Feb. 2021, pp. 7–13. Pubmed, doi:10.1139/bcb-2020-0217.
Kaufman DA, Berenz A, Itell HL, Conaway M, Blackman A, Nataro JP, Permar SR. Dose escalation study of bovine lactoferrin in preterm infants: getting the dose right. Biochem Cell Biol. 2021 Feb;99(1):7–13.

Published In

Biochem Cell Biol

DOI

EISSN

1208-6002

Publication Date

February 2021

Volume

99

Issue

1

Start / End Page

7 / 13

Location

Canada

Related Subject Headings

  • Urinary Tract Infections
  • Prospective Studies
  • Lactoferrin
  • Infant, Premature
  • Infant, Newborn
  • Humans
  • Enterocolitis, Necrotizing
  • Dietary Supplements
  • Cattle
  • Birth Weight