Pilot Study: Lactoferrin for Prevention of Neonatal Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis
Study type: Interventional
Phase: Phase 2

Summary: 
      We will test the hypothesis that bovine lactoferrin supplementation prevents serious
      infections in preterm infants. We will conduct a randomized placebo-controlled double blind
      study in 190 premature infants <2500 gm in 5 Neonatal Intermediate and Intensive Care Units
      in Lima, Peru to determine whether bovine lactoferrin prevents the first episode of
      late-onset sepsis.
    

Detailed description: 
      Lactoferrin is an iron chelating protein with multiple physiological functions
      (anti-microbial, anti-inflammatory and immunomodulatory) and is one of the most important
      proteins present in mammalian milk. We hypothesize that lactoferrin as an oral supplement
      given daily to low birth weight will improve their health by mimicking their protective role
      in milk. There is extensive literature showing in vitro and in animal models the benefits of
      lactoferrin. However, there are few clinical trials designed to translate this knowledge into
      patient care.

      We will conduct a pilot randomized, double-blinded placebo-controlled trial comparing daily
      supplementation with bovine lactoferrin versus placebo in neonates to reduce the incidence of
      sepsis in the first month of life. We will enroll 190 neonates with a birth weight less than
      2,500 g, younger than 3 days of age in the neonatal intensive care unit of 5 pediatric
      hospitals in Lima, after informed consent of both parents. Infants will be followed in the
      hospital until death or discharge and then at home up to 1 month of age. Bovine lactoferrin
      will be used in this trial (200 mg/Kg per day). Although bovine and human lactoferrin are not
      identical, their bioactivity is quite comparable. Maltodextrin (an inert sugar) will be used
      for controls. The primary study outcome will be the number of first late-onset sepsis
      episodes (occurring >72h after birth with isolation of any pathogen in blood or cerebrospinal
      fluid).
    

Intervention name(s): lactoferrin; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Infants will receive oral bovine lactoferrin (200 mg/Kg/day divided in three dosis) for 4 weeks. Lactoferrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum lactoferrin concentration will be 25mg/mL.; Infants will receive oral maltodextrin (200mg/Kg/day in three divided dosis) for 4 weeks. Maltodextrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum maltodextrin concentration will be 25mg/mL.
Other intervention name(s): Bovine lactoferrin
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: lactoferrin; sepsis; neonates; prevention; infections