Efficacy And Safety Of Short Course Antibiotic Therapy (72hrs) As Compared To Standard Duration (5-7 Days) Of Therapy In Preterm Neonates With Culture Negative Early Onset Sepsis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Incidence of 'Treatment Failure'
研究概览
简要总结
Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset sepsis.
详细描述
Enrolled participants will be randomly allocated to one of two study groups: 1) Short duration antibiotic' (72hrs), 2) Standard duration antibiotic'(5 - 7days)
Short duration antibiotic group: Antibiotic therapy stopped at the time of randomization i.e. 72 hours after starting antibiotics
Standard duration antibiotic group: antibiotics therapy continued for 5-7 days further after 72 hrs of starting antibiotics.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(All must be present)
- •All Preterm neonates (Gestational age >28weeks and >1000grams)
- •age less than 72hours of life
- •Started on antibiotic therapy based on presence of symptoms attributable to sepsis and /or positive sepsis screen but sterile blood culture
- •Symptoms resolved at time of randomization
排除标准
- •Antibiotics started based on risk factors
- •Infants with major congenital anomalies or syndromes.
- •Presence of site specific infections including meningitis, pneumonia
- •Neonates suspected to have inborn errors of metabolism
- •Neonates with Severe birth asphyxia, (Apgar score at 5min <4 and cord Ph< 7.0,base excess <-16)
- •Neonates underwent major surgery in 1st week of life
- •Deemed by Doctor in charge to be sick enough to be continued on antibiotics
研究组 & 干预措施
Short duration antibiotic
antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment
干预措施: Short duration antibiotics (Other)
Standard duration antibiotic
Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.
干预措施: Standard duration antibiotics (Other)
结局指标
主要结局
Incidence of 'Treatment Failure'
时间窗: 15 days of stopping antibiotics
New onset appearance of clinical signs and symptoms requiring initiation of antibiotics
次要结局
- Mortality(Till 1 month of life)
- Need for additional courses of antibiotic therapy(Till 1 month of life)
- Length of hospital stay(From date of birth until date of death or discharge whichever come assessed till 1 month of life)
研究者
Sushma Nangia, M.D.
Director Professor & Head, Department of Neonatology
Lady Hardinge Medical College