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临床试验/NCT01164124
NCT01164124已完成2 期

Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

Vermont Oxford Network6 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2008年2月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
101
试验地点
6
主要终点
Growth

研究概览

简要总结

The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain.

详细描述

The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain. The study also will evaluate the benefit of that feeding supplement in decreasing the rate of infection (in the blood or in the urine) and antibiotics use in those infants.

When babies are born, the digestive system (the gastrointestinal tract) is sterile. There are no bacteria residing in their gut. When babies start feeding, it is normal for the intestine to start growing several types of bacteria. These normal (good) bacteria are thought to be helpful in keeping the intestine healthy. This is not the case in premature infants. It takes premature infants a longer time to grow bacteria in their intestines and they have fewer numbers of bacteria. In addition, the bacteria premature infants grow are not the normal one that we see in healthy infants. Instead they grow unhealthy (bad) bacteria that can potentially play a role in causing infection in the blood and urine.

Adding the normal (good) bacteria to the breast milk or infant formula might help to protect premature babies from developing blood or urine infection. In addition, adding the good bacteria might be beneficial in terms of better tolerance to milk feeding. As a result, babies may have less episodes of feeding holding and have better weight gain. Two species of bacteria, called Lactobacillus and Bifidobacteria, have been used to study this in other studies of premature babies. These two species are the most plentiful bacteria seen in the bowels of full term babies.

Participation in the study involves enrolling premature babies to receive supplement to the feeding when he/she ready to feed. Babies will be randomly assigned to receive either a bacteria (probiotic) supplement or be fed without supplement. The supplement will be added to one feeding each day. Enrolled babies will continue to get the supplement for 6-10 week. Other than the feeding supplement, being in this study will not affect care.

The main outcomes of the study will be feeding tolerance and growth. Other complications associated with prematurity, on particular infection of either the gastrointestinal tract or the blood stream will be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Day 至 14 Days(Child)
性别
All
接受健康志愿者

入选标准

  • birth weight less than or equal to 1000 grams,
  • appropriately grown for gestational age,
  • age 1 to 14 days inclusive,
  • intention to start enteral feeds,
  • written informed consent obtained

排除标准

  • known life-threatening congenital anomaly or condition affecting
  • gastrointestinal function,
  • previous NEC or gastrointestinal perforation,
  • previous supplementation with probiotics
  • previous enteral feedings

研究组 & 干预措施

Probiotic supplementation

Experimental

500 million CFU of Lactobacillus rhamnosus GG (Culturelle, Amerifit Brand Inc.) and 500 million CFU of Bifidobacterium infantis (Align, Procter & Gamble.Inc)

干预措施: Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis) (Dietary Supplement)

Routine feedings

Placebo Comparator

干预措施: Placebo (Other)

结局指标

主要结局

Growth

时间窗: 28 days from study entry

Average weight gain and growth velocity during the first 28 days from initiation of feeding.

Feeding Tolerance

时间窗: 28 days from study entry

Volume of feeding per day during the first 28 days from the initiation of feeding.

次要结局

  • Complications of prematurity(until hospital discharge)
  • Antimicrobial therapy(34 weeks post menstrual age)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (6)

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