Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of participants with invasive fungal infection (IFI)
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •80 preterm
- •≤ 36 weeks gestational age
- •>/ = 72 hours of life
排除标准
- •Nothing per os
- •Congenital anomalies.
- •Suspected inborn error of metabolism.
- •Prophylaxis antifungal drugs
研究组 & 干预措施
Lactoferrin Bovine group
Group A (20 preterm neonates) which will receive lactoferrin (100mg/day)
干预措施: Lactoferrin Bovine (Drug)
Lactoferrin Bovine with probiotics group
Group B (20 preterm neonates) which will receive lactoferrin (100mg/day) in combination with the probiotic
干预措施: Lactoferrin Bovine and probiotics (Combination Product)
Placebo group
Group C (40 preterm neonates) which is a placebo group.
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with invasive fungal infection (IFI)
时间窗: 12 months
Efficacy of enteral lactoferrin either alone or in combination with the probiotic Lactobacillus Delbrueckii and Lactobacillus Fermentum in the prevention of invasive fungal infections in preterm infants through analyzing the incidence rates of invasive fungal infection (IFI) in all groups using Sabouraud agar for detecting Candida species and Hichrome agar to detect other fungal types.
次要结局
- Mortality in each group(12 months)
- Days on inotropic support in each group(12 months)
- Days on mechanical ventilation in each group(12 months)
- Days of NICU admission in each group(12 monthes)
- Number of participants with Necrotizing enterocolitis in each group(12 months)
- Number of patients who received packed RBC in each group(30 days)
研究者
Hebatallah A Shaaban, MD
Principal Investigator
Ain Shams University