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Transcutaneous Microcirculatory Imaging in Preterm Neonates
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Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants.

Michael P Sherman1, David H Adamkin2, Victoria Niklas3

  • 1Division of Neonatology, Department of Child Health, University of Missouri, Columbia, MO.

The Journal of Pediatrics
|June 5, 2016
PubMed
Summary

Recombinant human lactoferrin (talactoferrin [TLf]) showed a trend toward reduced infections in preterm infants without causing toxicity. This study explored TLf

Keywords:
VLBW infanthospital-acquired infectionlactoferrinsafety

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Area of Science:

  • Neonatal Medicine
  • Infectious Diseases
  • Pharmacology

Background:

  • Preterm infants are highly susceptible to hospital-acquired infections.
  • Early-life infections pose significant risks to infant health and development.
  • Novel therapeutic strategies are needed to prevent infections in vulnerable neonates.

Purpose of the Study:

  • To evaluate the safety of recombinant human lactoferrin (talactoferrin [TLf]).
  • To explore the efficacy of TLf in reducing infections in preterm infants.
  • To assess the impact of TLf on various infectious and noninfectious outcomes.

Main Methods:

  • A randomized, double-blind, placebo-controlled trial was conducted.
  • Infants (birth weight 750-1500 g) received enteral TLf or placebo for 28 days.
  • Primary outcomes included bacteremia, pneumonia, UTI, meningitis, and NEC; secondary outcomes included sepsis syndrome and suspected NEC.

Main Results:

  • No clinical or organ-specific adverse events were attributed to TLf.
  • Hospital-acquired infections were 50% lower in the TLf group (P < .04).
  • Fewer gram-negative infections were observed in TLf-treated infants, particularly those weighing <1 kg.

Conclusions:

  • Talactoferrin was found to be safe with no clinical or laboratory toxicity.
  • A trend toward reduced infectious morbidity was observed in infants treated with TLf.
  • Further research may elucidate TLf's role in preventing infections in preterm neonates.