Efficacy of Bifidobacterium Animalis Subsp. Lactis as an Adjunct to Phototherapy in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Duration of phototherapy
研究概览
简要总结
This study aims to evaluate the effectiveness of adjunctive oral Bifidobacterium animalis subsp. lactis in term neonates with indirect hyperbilirubinemia receiving phototherapy. The study will compare the effects of adjunctive probiotics plus standard phototherapy with standard phototherapy alone on the duration of phototherapy, length of hospital stay, serum total bilirubin reduction, phototherapy-related adverse events, and hospital readmission after discharge.
详细描述
Eligible term neonates with indirect hyperbilirubinemia requiring phototherapy will be randomly assigned to either the intervention group or the control group.
Neonates in the intervention group will receive oral Bifidobacterium animalis subsp. lactis (1 × 10⁹ CFU/day) in addition to standard phototherapy from the initiation of phototherapy until its discontinuation.
Neonates in the control group will receive standard phototherapy alone according to the hospital protocol.
All participants will undergo clinical evaluation and serum total bilirubin measurement before treatment and at day 3 of phototherapy. During hospitalization, the duration of phototherapy, length of hospital stay, serum bilirubin levels, and phototherapy-related adverse events will be recorded. Hospital readmission, including the occurrence, number, and primary reason for readmission, will be assessed at 28 days, 3 months, and 6 months of age.
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
- None
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 0-28 days.
- •Gestational age 37-42 weeks.
- •Diagnosed with indirect hyperbilirubinemia according to the AAP 2022 guidelines.
- •Eligible for phototherapy based on serum total bilirubin levels
- •Informed consent obtained from a parent or legal guardian.
排除标准
- •Direct hyperbilirubinemia (direct bilirubin >2.0 mg/dL and >20% of total serum bilirubin).
- •Major congenital anomalies or severe concurrent illness (e.g., respiratory failure, intracranial hemorrhage).
- •Indication for exchange transfusion, intravenous immunoglobulin (IVIG) or phenobarbital according to the AAP 2022 guidelines.
- •Neonatal sepsis, blood group incompatibility, glucose-6-phosphate dehydrogenase deficiency, red blood cell membrane disorders.
- •Suspected gastrointestinal obstruction.
- •Unable to tolerate oral feeding.
研究组 & 干预措施
Phototherapy and Probiotics
Children will receive standard phototherapy in combination with oral Bifidobacterium animalis subsp. lactis throughout the phototherapy period.
干预措施: Bifidobacterium animalis subsp. lactis (Drug)
Phototherapy
Children will only receive standard phototherapy without adjunctive probiotic supplementation.
干预措施: Standard Phototherapy (Other)
结局指标
主要结局
Duration of phototherapy
时间窗: From time of initiation of phototherapy until discontinuation of phototherapy, assessed up to 28 days of age
The total duration of phototherapy, measured in hours
Change in serum total bilirubin level
时间窗: At baseline and day 3 of treatment
The difference between serum total bilirubin levels measured before treatment initiation and at day 3 of treatment
次要结局
- Length of hospitalization(From date of hospital admission until the date of hospital discharge, assessed up to 28 days of age)
- Adverse events(From time of initiation of phototherapy until discontinuation of phototherapy, assessed up to 28 days of age)
- Rate of Hospital readmission(At 28 days, 3 months, and 6 months of age)
- Number of Hospital readmissions(At 28 days, 3 months, and 6 months of age)
- Reason for Hospital Readmission(At 28 days, 3 months, and 6 months of age)
研究者
Hua Thi Ngan Tam
Principal Investigator
Can Tho University of Medicine and Pharmacy