跳至主要内容
临床试验/CTRI/2012/08/002853
CTRI/2012/08/002853尚未招募3 期

Effect of Probiotics on Feed Tolerance in Very Low Birth Weight Neonates- A Randomized Controlled Trial

DrShashidharA1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2012年8月31日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
126
试验地点
1
主要终点
time to reach full enteral feeds

研究概览

简要总结

Enteral feeding intolerance is a major problem in premature infants, resulting in prolonged hospitalisation and a predisposition to serious complications due to prolonged use of parenteral nutrition.Second to prematurity, feedings and feeding practices are frequently implicated in the development of necrotizing enterocolitis. Enteral supplementation of probiotics prevents severe NEC and all-cause mortality in preterm infants. Review of available evidence supports a change in practice  Following recent data, many centres are currently supplementing preterm infants routinely with probiotics.

 Feeding intolerance has been considered as a precursor of NEC and many strategies have been tried in its prevention.Probiotics by themselves, or stimulated by prebiotic fermentation, are important modulators of the intestinal immune system, helps to produce a balanced T-helper cell response and prevents an imbalance contributing in part to clinical disease. An adequate establishment of the intestinal flora after birth is strictly related to motility maturation and plays a crucial role in the development of gut barrier function and the innate and adaptative immune system. In some RCTs done for prevention of NEC, probiotics have been shown to reduce time to full feeds, hospitalization days and days on total parenteral nutrition (TPN).

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • All neonates (infants in the first 28 days of life) with a birth weight less than 1.5kg, admitted to NICU SJMCH Bangalore.
  • Postnatal age <2wks and started enteral feeds.

排除标准

  • •Neonates GI tract anomalies, severe congenital malformations.
  • •Refusal of consent.
  • •Not started enteral feeds by day 14 of life.
  • •Outborn babies fed within 72 hrs.

结局指标

主要结局

time to reach full enteral feeds

时间窗: till discharge

次要结局

  • oincidence of feed intolerance(oincidence of NEC stage 2 or more)

研究者

发起方
DrShashidharA
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验