Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia
试验速览
- 阶段
- 3 期
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Duration of phototherapy
研究概览
简要总结
Neonatal Jaundice occurs in 60% of term infants and 80% of premature infants. Although it is transient, it is associated with high rate of readmission of patients in the first week of infancy. Neonatal jaundice can cause neurological complications and kernicterus. Considering the fact that there have been a lot of studies on probiotic role in management of necrotizing enterocolitis (NEC) and few studies on their role in neonatal jaundice, we carried out this study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia in infants hospitalized in children hospital in Bandar Abbas.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 2 and 28 days old
- •Having jaundice
- •Gestational age between 35-42 weeks
排除标准
- •Less than 2 days or more than 28 days old
- •Gestational age out of the range of 35-42 weeks
- •Infants whose parents refused to cooperate
- •Patients with sepsis and other comorbid conditions
研究组 & 干预措施
Probiotic
Routine phototherapy plus probiotic oral drops at the dose of 10 drops daily
干预措施: Probiotic (Drug)
结局指标
主要结局
Duration of phototherapy
时间窗: 6 days
Duration of phototherapy
次要结局
- Discharge rate(6 days)
研究者
Hamidreza Mahboobi
Principle Investigator
Hormozgan University of Medical Sciences