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临床试验/NCT05848492
NCT05848492已完成3 期

Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.

Services Institute of Medical Sciences, Pakistan1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年5月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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

发起方
Services Institute of Medical Sciences, Pakistan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Muhammad Tauseef Omer

Post-graduate resident

Services Institute of Medical Sciences, Pakistan

研究点 (1)

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