Pilot Study: Lactoferrin for Prevention of Neonatal Sepsis (NEOLACTO)
|Sepsis||Dietary Supplement: lactoferrin Dietary Supplement: Maltodextrin||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Pilot Study: Lactoferrin for Prevention of Neonatal Sepsis|
- Number of confirmed episodes of late-onset sepsis. [ Time Frame: 1 month ]Number of confirmed episodes of late-onset sepsis in the first month of life
- Incidence of Gram positive and Gram negative bacterial and fungal bouts of sepsis, pneumonia, diarrhea and mortality [ Time Frame: 1 month ]Incidence of Gram positive and Gram negative bacterial and fungal bouts of sepsis, pneumonia, diarrhea and mortality in the first month of life.
|Study Start Date:||December 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Lactoferrin is a freeze-dried protein purified directly from fresh bovine milk.
Dietary Supplement: lactoferrin
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.
Other Name: Bovine lactoferrin
Placebo Comparator: maltodextrin
Maltodextrin is an inert sugar.
Dietary Supplement: Maltodextrin
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264536
|Hospital Nacional Alberto Sabogal Sologuren|
|Callao, Lima, Peru, Callao2|
|Hospital Guillermo Almnara Irigoyen|
|Lima, Peru, Lima13|
|Hospital Nacional Cayetano Heredia|
|Lima, Peru, Lima31|
|Principal Investigator:||Theresa J Ochoa, MD||Universidad Peruana Cayetano Heredia|