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