Related Experiment Video
Updated: Mar 20, 2026
Transcutaneous Microcirculatory Imaging in Preterm Neonates
Published on: December 31, 2015
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.
Insights
Recombinant human lactoferrin (talactoferrin [TLf]) showed a trend toward reduced infections in preterm infants without causing toxicity. This study explored TLf
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.
Objective:
To evaluate the safety and explore the efficacy of recombinant human lactoferrin (talactoferrin [TLf]) to reduce infection.
Study Design:
We conducted a randomized, double blind, placebo-controlled trial in infants with birth weight of 750-1500 g. Infants received enteral TLf (n = 60) or placebo (n = 60) on days 1 through 28 of life; the TLf dose was 150 mg/kg every 12 hours. Primary outcomes were bacteremia, pneumonia, urinary tract infection, meningitis, and necrotizing enterocolitis (NEC). Secondary outcomes were sepsis syndrome and suspected NEC. We recorded clinical, laboratory, and radiologic findings, along with diseases and adverse events, in a database used for statistical analyses.
Results:
Demographic data were similar in the 2 groups of infants. We attributed no enteral or organ-specific adverse events to TLf. There were 2 deaths in the TLf group (1 each due to posterior fossa hemorrhage and postdischarge sudden infant death), and 1 death in the placebo group, due to NEC. The rate of hospital-acquired infections was 50% lower in the TLf group compared with the placebo group (P < .04), including fewer blood or line infections, urinary tract infections, and pneumonia. Fourteen infants in the TLf group weighing <1 kg at birth had no gram-negative infections, compared with only 3 of 14 such infants in the placebo group. Noninfectious outcomes were not statistically significantly different between the 2 groups, and there were no between-group differences in growth or neurodevelopment over a 1-year posthospitalization period.
Conclusion:
We found no clinical or laboratory toxicity and a trend toward less infectious morbidity in the infants treated with TLf.
Trial Registration:
ClinicalTrials.gov: NCT00854633.
More Related Videos
07:11Assessment of the Efficacy of An Osteopathic Treatment in Infants with Biomechanical Impairments to Suckling
Published on: February 5, 2019
04:53A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019