COMPARATIVE EFFECTS OF ZINC AND PROBIOTICS ON NEONATAL INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Rate of decline in Bilirubin levels during phototherapy with this adjuvant therapy
研究概览
简要总结
Study will evaluate effects of oral zinc and probiotics supplementation in neonates who have indirect hyperbilirubinemia and are receiving phototherapy. Aim is to compare efficacy of these two drugs in clearing bilirubin and reducing duration of phototherapy. Neonates will be randomly assigned to receive either drug alongside phototherapy.
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
- Double (Participant, Care Provider)
盲法说明
Both participants and care provider will be blinded to intervention allocation. Preparation of both drugs will be made identical in appearance and packaging to ensure unbiased administration and assessment during phototherapy.
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term or Near term neonates
- •Age <7 days at enrollment
- •Bilirubin levels within phototherapy range according to NICE bilirubin threshold charts
- •No identifiable pathology
- •Tolerating oral feeds
- •Parental or Guardian written informed consent taken.
排除标准
- •Positive sepsis screen or clinical signs of infection
- •Direct hyperbilirubinemia
- •Gastrointestinal malformations
- •Oral intolerance
- •Requiring mechanical ventilation
- •Congenital anomalies
- •Parental or Guardian refusal to participate in study
研究组 & 干预措施
Zinc group
Participants in this group will receive oral zinc following neonatal dosing guidelines.
干预措施: Zinc sulfate (Drug)
Probiotics group
Participants in this group will receive oral probiotics following neonatal dosing guidelines.
干预措施: Probiotic lactobacillus rhamnosus GG (Drug)
结局指标
主要结局
Rate of decline in Bilirubin levels during phototherapy with this adjuvant therapy
时间窗: From initiation of supplementation with phototherapy to its completion (typically 3-7 days).
Primary outcome measures the rate at which total serum bilirubin decreases in mg/dL per day in neonates undergoing phototherapy while receiving supplementation with either zinc or probiotics. Bilirubin levels will be recorded at baseline and at regular intervals until phototherapy is discontinued and hence rate of decline will be calculated.
次要结局
未报告次要终点
研究者
Malik Muhammad Umair Fazal
Dr. Malik Muhammad Umair Fazal
Quaid-e-Azam Medical College