Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates
Condition: Fungal Infection
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The risk for invasive fungal infections is high in very low birth weight (VLBW) infants (<
      1500 g) and highest for infants born at the youngest gestational ages who survive past the
      immediate postnatal period.

      Invasive fungal infections (IFIs) represent an increasing cause of severe morbidity and
      mortality in most neonatal intensive care units.

      Lactoferrin (LF) is secreted by epithelial cells into exocrine fluids: seminal fluid, tears,
      saliva, uterine secretions, and milk. LF is involved in innate immunity mechanisms with
      several documented anti-infective properties, including antifungal activity.

      Probiotics are microorganisms that are believed to provide health benefits when consumed.

      It is possible to adopt measures to modify the flora in our bodies and to replace the harmful
      microbes by useful microbes.

      There are certain commercially available strains of probiotic bacteria from the Bifido
      bacterium and Lactobacillus genera when taken by mouth in daily doses possess treatment
      efficacy
    

Detailed description: 
      Bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus
      Fermentum) can be used in prevention of invasive fungal infection in preterm neonates
      admitted to the NICU. So, this randomized interventional study aimed at evaluation of the
      efficacy and safety of enterally administered bovine LF alone or in combination of probiotics
      (Lactobacillus Delbrueckii and Lactobacillus Fermentum) in comparison to placebo in preterm
      neonates, through studying blood culture for fungal infection at enrollment, day 7, 14, 21
      and 28 using Sabouraud agar for detecting Candida species and Hichrome agar to detect other
      fungal types ( primary outcome), and to compare length of hospital stay (LOS), use and
      duration of drug intake as antibiotics and inotropes, use and duration of mechanical
      ventilation, rate of increase of enteral feeding, time to reach full enteral intake, signs of
      feeding intolerance, complete blood count (CBC), C reactive protein (CRP), packed red blood
      cell transfusion (PRBCs) and mortality between the 3 groups as (secondary outcome).
    

Intervention name(s): Lactoferrin Bovine; Lactoferrin Bovine and probiotics; Placebo
Intervention type(s): Drug; Combination Product; Other
Intervention description(s): Lactoferrin granules (Pravotin®) in a dose of 100 mg /kg/day starting from birth to the 30th day of life for neonates in group A; Lactoferrin granules (Pravotin®) in a dose of 100 mg /kg/day in combination with the probiotic Lactobacillus Delbrueckii and Lactobacillus Fermentum (Lacteol fort®) given in a dose of 5 billions starting from birth to the 30th day of life for neonates in group B; Placebo will be given starting from birth to the 30th day of life for neonates in group C.
Other intervention name(s): Pravotin®; Pravotin® plus Lacteol fort
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Lactoferrin; Probiotic; Preterm