Effect of oral zinc supplementation in term neonates undergoing phototherapy for hyperbilirubinemia in an industrial hospital, a randomised control trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Rate of fall of total serum bilirubin levels.
研究概览
简要总结
In this study, we will compare the effect of oral zinc supplementation in term neonates undergoing phototherapy for hyperbilirubinemia with others receiving only phototherapy in terms of rate of fall in serum bilirubin value and duration of phototherapy at TATA MOTORS HOSPITAL, JAMSHEDPUR.
I want to perform this study because the result will give a novel method of treatment for age old hyperbilirubinemia, reducing NICU stay and newborn and mother separation.
Approval of the instititional ethical committee was taken beforehand.
Written informed consent will be taken prior to the study. Caregivers and patients will be informed about the purpose of study and strict confidentiality will be ensured.
All the patients fitting into the inclusion criteria at NICU, Department of Paediatrics will be enrolled and proper history, examination and relevant investigations will be done.
Data collected wiil be analysed by preliminary data inspection, content analysis and interpretation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Term neonates with indirect hyperbilirubinemia under phototherapy range.
排除标准
- •Preterm neonates.
- •Direct hyperbilirubinemia.
- •Systemic illness.
- •Severe sepsis.
- •Severe respiratory disease requiring mechanical ventilation Oral intolerance.
- •Major gross congenital anomalies (GI malformations, heart and neural tube defects etc).
- •Term neonates with hyperbilirubinemia in exchange transfusion range.
结局指标
主要结局
Rate of fall of total serum bilirubin levels.
时间窗: 3 DAYS
次要结局
- Duration of phototherapy.(3 DAYS)