Probiotic as add on to Phototherapy versus Phototherapy alone in Neonatal Hyperbilirubinemia: An Open-label Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
Neonatal hyperbilirubinemia that causes yellowing of skin , conjuctiva due to raised serum pr plasma bilirubin within 2-3 days of birth It is found in about 60% term and 80% preterm infants during 1st week of life. Due to delayed and insufficient colonization of GI flora in early stage tof neonates .There are few microbiota involved in bilirubin meta bolism resulting in decreased conversation of conjugated bilirubin to stercobilin. U conjugated bilirubin collects in intestine and recirculated leading to increased serum bilirubin level.Adjuvent probiotics in neonatal jaundice treatment is new area of interest for declining serum bilirubin levels along with phototherapy.
There will be two groups of neonates allocated via simple randomisation technique First with phototherapy with probiotics and other is phototherapy alone.These modalities will be continued till bilirubin levels fall below phototherapy cutoff at two intervals or max for 7 days or probiotics will be given max. for 7 days .we will assess the role of probiotics on phototherapy duration in neonatal hyperbilirubinemia .
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
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •All neonates with gestational age more than 35 weeks to 41 +6weeks who will reach the threshold for photography according to AAP 2022 guidelines for neonatal hyperbilirubinemia.
排除标准
- •Preterm neonates more than 35 weeks.
- •Elevated direct bilirubin levels.
- •Any clinical or laboratory evidence of infection, any gross congenital malformations, glucose 6-phosphate dehydrogenase deficiency, history of maternal phenobarbital intake.
- •Critically sick neonates undergoing mechanical ventilation or in shock or on vasopressor support.
- •Neonates with critical heart disease, critical renal system anomaly, critical respiratory or gastrointestinal tract disease.
- •Neonates who previously received phototherapy.
- •Serum bilirubin levels reached the standard for exchange blood transfusion.
- •Refusal of consent by parents/guardian.
研究者
Dr NDVaswani
Pandit Bhagwat Dayal Sharma PGIMS ROHTAK