Sepsis Clinical Trial
Official title:
Pilot Study: Lactoferrin for Prevention of Neonatal Sepsis
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.
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).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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