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Summary Protocol for a Multi-Centre Randomised Controlled Trial of Enteral Lactoferrin Supplementation in Newborn

    Neonatology
    |June 12, 2018
    PubMed

    Insights

    This study investigates if bovine lactoferrin supplementation for very preterm infants reduces infections and improves outcomes. The research aims to assess its effectiveness and cost-efficiency in neonatal care.

    Area of Science:

    • Neonatal Medicine
    • Pediatric Infectious Diseases
    • Clinical Nutrition

    Background:

    • Very preterm infants (< 32 weeks' gestation) face high risks of infection and mortality.
    • Late-onset invasive infections are a significant complication in neonatal intensive care.

    Purpose of the Study:

    • To evaluate the efficacy of prophylactic enteral bovine lactoferrin in reducing late-onset invasive infections in very preterm infants.
    • To assess the impact of lactoferrin on mortality, bronchopulmonary dysplasia, necrotising enterocolitis, retinopathy of prematurity, and healthcare resource utilization.

    Main Methods:

    • Multi-centre randomised controlled trial (RCT) involving 2,200 very preterm infants.
    • Intervention: Prophylactic enteral bovine lactoferrin (150 mg/kg/day) from birth until 34 weeks' post-menstrual age.
    • Economic evaluation to assess cost-effectiveness alongside the RCT.

    Main Results:

    • Primary outcome: Incidence of late-onset invasive infection.
    • Secondary outcomes: All-cause mortality, bronchopulmonary dysplasia, necrotising enterocolitis, retinopathy of prematurity, duration of antibiotic exposure, intensive care, and hospital stay.
    • Economic analysis of incremental costs and cost-effectiveness.

    Conclusions:

    • The study will determine if enteral lactoferrin supplementation is a beneficial strategy for very preterm infants.
    • Findings will inform clinical practice regarding infection prevention and resource management in neonatal care.
    • Potential for future research into long-term neuro-developmental outcomes if primary outcome is met.

    Keywords:
    InfectionLactoferrinPreterm infants

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