Determination of the Effect of Vitamin-D as an Adjuvant to Phototherapy in Reduction of Indirect Serum Bilirubin Among Neonates With Exaggerated Physiological Hyperbilirubinemia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Bilirubin reduction comparison
研究概览
简要总结
The study aimed at filling the gaps by evaluating the effectiveness of vitamin-D as an adjuvant to phototherapy in reduction of indirect serum bilirubin among neonates with exaggerated physiological hyperbilirubinemia.
详细描述
If vitamin-D has been found effective as an adjuvant to phototherapy in the treatment of exaggerated physiological hyperbilirubinemia, it may help to reduce the serum bilirubin level rapidly. It may also reduce the complications by shortening the duration of phototherapy to offer better patient compliance and better patient outcomes.
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
- 3 Days 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns of any gender
- •Age of 3rd day of life to 8th day of life
- •Gestation age ≥37 to ≤42 weeks
- •Total serum bilirubin level more than 12.9 mg/dL
- •Weight > 2.5 kg
排除标准
- •Congenital defects (on physical examination)
- •Large for gestational age infant
- •Rh Incompatibility (were excluded on basis of blood grouping of mother and baby)
- •ABO Incompatibility (were excluded on basis of blood grouping of mother and baby)
- •Neonatal sepsis
研究组 & 干预措施
Vitamin D3 group
Neonates were given vitamin D3 (cholecalciferol) in an oral drops formulation (400 IU/drop), at a dose of 400 IU once a day for 72 hours as an adjuvant therapy to phototherapy.
干预措施: Vitamin D3 (Drug)
Vitamin D3 group
Neonates were given vitamin D3 (cholecalciferol) in an oral drops formulation (400 IU/drop), at a dose of 400 IU once a day for 72 hours as an adjuvant therapy to phototherapy.
干预措施: Phototherapy (Procedure)
Phototherapy group
Neonates received only phototherapy for 72 hours.
干预措施: Phototherapy (Procedure)
结局指标
主要结局
Bilirubin reduction comparison
时间窗: 72 hours
Net reductions in bilirubin levels in two groups after 72 hours were compared.
次要结局
未报告次要终点
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research