CTRI/2024/04/065593尚未招募4 期
To study the efficacy of Probiotics along with Phototherapy and phototherapy alone in neonatal hyperbilirubinemia: A Randomized Controlled Trial
Government Medical College Rajindra Hospital Patiala1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年4月26日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- serum bilirubin level lowering efficacy of probiotics along with phototherapy vs phototheray alone in patients of neonatal hyperbilirubinemia
研究概览
简要总结
This will be a randomized clinical trial including 150 neonates diagnosed with neonatal hyperbilirubinemia. Patients will be randomized to two groups - phototherapy with oral probiotics (Darolac) and phototherapy alone through stratified randomization. Serum Bilirubin Levels (SBL) at the time of intervention, 24, 48, and 72 hours later, duration of phototherapy, duration of hospitalization, and any side effect related to intervention will be assessed and compared in the two groups
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 21.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm and term neonates with hyperbilirubinemia (35-40 weeks)
- •Patients with jaundice due to maternal blood type ABO compatibility
- •G6PD deficiency
- •Hypothyroidism 5.
排除标准
- •Patients with gestational age less than 35 weeks.
- •Patients with severe cardiopulmonary illness.
- •Patients with birth weight less than 2,000 grams.
- •Patients having signs of perinatal asphyxia.
- •Patients with congenital anomalies.
- •Patients whose parents refuse to give written informed consent.
结局指标
主要结局
serum bilirubin level lowering efficacy of probiotics along with phototherapy vs phototheray alone in patients of neonatal hyperbilirubinemia
时间窗: Day-1, 24 hours, 48 hours and 72 hours
次要结局
- change in duration of phototherapy in probiotics along with phototherapy and phototherapy alone treatment group(Day-1, 24 hours, 48 hours and 72 hours)
研究者
Dr Amanpreet Kaur
Government Medical College & Rajindra Hospital Patiala
研究点 (1)
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