Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Invasive candidiases
研究概览
简要总结
Invasive fungal infection is detecting candida species in blood, cerebrospinal fluid, or urine. Clinical signs of invasive candidiasis may include lethargy, temperature instability, feeding intolerance, apnea, hypotension, respiratory distress, abdominal distension, and thrombocytopenia. Fungal infection has been associated with an increased risk of retinopathy of prematurity and chronic lung disease. Preterm and low birth weight infants have an immature immune system that predisposes them to infections with bacteria, viruses, and fungi. These infants usually require prolonged admission in the neonatal unit and there is often a need for the administration of broad-spectrum antibiotics which predisposes them to colonization with fungi that may invade to cause systemic disease8. Other risk factors for the development of invasive fungal infection include endotracheal intubation, abdominal surgery, the presence of a central venous catheter, administration of H2 antagonists, and steroids. Infection with Candida species is the third most common cause of bloodstream infection in premature infants. Mortality in preterm infants due to invasive candidiasis is around 20% and can be as high as 50% in infants weighing <1500g at birth. Invasive candidiasis is the second most common infectious cause of death in extremely preterm infants. The present study was conducted to determine the incidence of invasive candidiasis among preterm and very low birth weight infants in our neonatal unit and to evaluate the efficacy of prophylactic fluconazole in preventing invasive fungal infection. Based on the results of the present study institutional guidelines may be designed in our neonatal unit relating to antifungal prophylaxis in preterm and very low birth weight infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 3 Days(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm babies born less than 34 weeks of gestation
- •very low birth weight babies (weighing < 1500 g at birth)
- •Babies <72 hours of age
排除标准
- •Babies >72 hours of life
- •Syndromic babies
- •Babies with suspected metabolic disorders
研究组 & 干预措施
Prophylactic Fluconazole
12 mg/Kg loading dose of fluconazole given intravenously followed by 6 mg/Kg every 48 hours till 14 days of life, and then 6 mg/kg/day thereafter, for a total duration of 6 weeks (42 days).
干预措施: Fluconazole (Drug)
placebo group
Normal Saline 2cc given intravenously
干预措施: Saline (Drug)
结局指标
主要结局
Invasive candidiases
时间窗: 2 weeks
Positive blood, cerebrospinal fluid, or urine culture for candida species will be regarded as invasive candidiasis.
次要结局
未报告次要终点
研究者
Muhammad Tauseef Omer
Post-graduate resident
Services Institute of Medical Sciences, Pakistan
