A Prospective Study to Analyze the Efficacy of IgM Rich Immunoglobulin as an Adjunct to Antibiotics in the Treatment of Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Discharge rates
研究概览
简要总结
Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and neonates will be monitored for the results. The data will be analysed on the basis of blood culture results and outcome of the patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Very low birth weight baby: birth weight 1-1.5 kg
- •Both inside and outside delivered babies
- •Gender: males and females
- •Probable severe sepsis (septic score)
排除标准
- •Extremely low birth weight babies: < 1 kg
- •Babies >1.5 kg birth weight
- •Babies born with congenital malformations
- •Full term babies
- •IUGR babies
- •Child with no signs of sepsis
- •HBsAg Positive
- •HIV Positive
研究组 & 干预措施
case group
'IgM rich immunoglobulin' intravenous infusion in the dose of 5 ml/ kg/ dose over 3 hours once a day for 3 days.
干预措施: IgM rich Immunoglobin (Drug)
control group
antibiotics only
干预措施: IgM rich Immunoglobin (Drug)
结局指标
主要结局
Discharge rates
时间窗: 6 months
patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics.
次要结局
- Duration of hospital stay(6 months)
研究者
Sonal V Jindal
Principal Investigator, Resident
Sir Takhtasinhji General Hospital