Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis (NEC) in Premature Neonates
试验速览
- 阶段
- 2 期
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Necrotizing Enterocolitis, Bell Stage 2 or above, or Death
研究概览
简要总结
Prophylactic probiotics have been shown to decrease the incidence of Necrotizing Enterocolitis (NEC) in premature neonates. However, there is some resistance to giving live bacteria to small babies. Based on animal data, the investigators hypothesized that heat inactivated probiotics would also reduce NEC.
详细描述
Preterm neonates, <1500 gm birth weight will potentially be candidates for study and will be recruited when they begin enteral feeding. The infants will be prospectively and randomly assigned to one of two groups:
- Treatment group - to receive daily inactivated probiotic prophylaxis starting with the initiation of feeds. 1 tsp powder will be diluted in 2 cc of mother's milk when possible or in Similac Special Care formula 24 cal when mother's milk is not available; and
- Control group - to receive 2 cc/day of placebo similarly diluted. Supplements will be continued until the infant tolerates enteral feeds of 100 cc/kg/day or reaches 35 weeks post conceptual age (whichever comes LAST). Biotikid, a probiotic mixture, will be heated to 100 degrees C for 10 minutes. Babies will be followed clinically for signs of NEC, and with urine intestinal fatty acid binding protein (IFABP) and fecal calprotectin levels.
The investigators primary aim is to demonstrate that premature neonates who are treated prophylactically with heat inactivated probiotics will have less necrotizing enterocolitis when compared to age matched infants given placebo.
The investigators secondary objectives are to demonstrate the following:
- That the decrease in NEC will coincide with improved intestinal barrier integrity, as reflected by levels of:
- I-FABP in urine
- Fecal Calprotectin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Hours 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates
- •≤1500 gm birth weight
排除标准
- •Infants who are not deemed likely to survive more than one week;
- •Infants who are not started on enteral feeds by one week of age;
- •Infants who have significant congenital malformations or other gastrointestinal problem
研究组 & 干预措施
Control Group
Dietary Supplement: Placebo 2 cc/day of placebo diluted in mother's milk (when available) or premature formula.
干预措施: Placebo (Dietary Supplement)
Treatment Group
Dietary Supplement: Heat Inactivated Probiotics
1 tsp heat inactivated Biotikid powder will be diluted in 2 cc of mother's milk (when available) or premature formula.
干预措施: Heat Inactivated probiotics (Dietary Supplement)
结局指标
主要结局
Necrotizing Enterocolitis, Bell Stage 2 or above, or Death
时间窗: Birth until 40 weeks post-conceptional age
Necrotizing Enterocolitis diagnosis will be based on clinical and radiographic criteria
次要结局
- Increased Urine IFABP Levels(Weekly, from date of randomization until full enteral feeds (100 cc/kg/day) achieved or until death or necrotizing enterocolitis is diagnosed, whichever comes first until 37 weeks postconceptional age)
- Increased Fecal Calprotectin Levels(Weekly, from date of randomization until full enteral feeds (100 cc/kg/day) achieved or until death or necrotizing enterocolitis is diagnosed, whichever comes first until 37 weeks postconceptional age)
研究者
Cathy Hammerman
Director Division Newborn Nurseries
Shaare Zedek Medical Center