Effects of Lactobacillus Rhamnosus GG Supplementation in Reducing serum bilirubin in neonates after 35 weeks of gestation as compared to only breast milk. A tertiary care center based one year study- a randomized controlled trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To assess the role of lactobacillus rhamnosus gg in reducing serum bilirubin levels in neonates.
研究概览
简要总结
Jaundice is one of the most common conditions requiring medical care in neonates. Neonatal jaundice is a very common condition and affects approximately 2.4- 15% of newborn babies during the first 2 weeks of life. A rise of serum bilirubin level above3 15 mg/dl increases susceptibility to irreversible neurodisability . Timely detection of hyperbilirubinemia and early intervention is of utmost importance to prevent long term neurodisability. Sufficient feeding with sunlight exposure is associated with reduced risk of hyperbilirubinemia. It is plausible that early administration of probiotics in neonates can prevent neonatal hyperbilirubinemiaas the new born intestinal microflora is not fully formed in the first days of life and this cause increase in bilirubin enterohepatic circulation. Probiotics reduce the enterohepatic circulation of bilirubin by reducing the activity of beta-glucoronidase by thus promoting its excreation. Lactobacillus rhamnosus GG is considered safe by the united states FDA and the most sought after probiotic used worldwide. The use of probiotics in neonates is well established in necrotising enterocolitis There have been limited number of studies in assessing its role in reducing the incidence of neonatal hyperbilirubinemia. Most number of interventional studies have been done in intensive care set up assessing the use of probiotics as a supplement to phototherapy in preterm neonates. Probiotic supplementation can also aid in maturation of the underdeveloped gut flora reducing the incidence of gastroenteritis and promoting the growth of healthy gut flora. There is a lacuna in finding the role of probiotics as a prophylaxis to reduce serum bilirubin level in term neonates. This study will help to decipher the effectiveness of probiotics in reducing serum bilirubin levels thus reducing the need for phototherapy which leads to prolongation of hospital stay and separation from mother.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Day(s) 至 6.00 Day(s)(—)
- 性别
- All
入选标准
- •Newborns born after 35 weeks of gestation from day 3 of life to day 6 of life.
排除标准
- •Neonate of a gestational diabetic mother.
- •Familial hematological disorder with signs of hemolysis.
- •Neonates requiring intensive care admission during first 3 days of life.
- •Neonates with congenital anomalies/malformations.
结局指标
主要结局
To assess the role of lactobacillus rhamnosus gg in reducing serum bilirubin levels in neonates.
时间窗: To assess the role of lactobacillus rhamnosus gg in reducing serum bilirubin levels in neonates over a period of first 5 days of life.
次要结局
未报告次要终点
研究者
Dr Pavitra Alva
JNMC Belagavi
