A randomised controlled trial comparing safety and efficacy of short course versus CRP guided antibiotic regimen for blood culture negative suspected neonatal sepsis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- All babies will be clinically reviewed 15 days after stopping antibiotics to look for any evidence of suspected sepsis
研究概览
简要总结
Sepsis is a common cause of morbidity and mortality in the neonatal period. As progression from initial symptoms to complications like shock, bleeding, cardio-respiratory failure can be rapid, many neonates are started on empirical antibiotics when they have a variety of symptoms of suspected sepsis after a sepsis screen.
Stopping antibiotics if blood culture is negative and baby is well is sometimes challenging. Many clinicians do a C Reactive Protein to decide if it is safe to stop antibiotics in this setting. However as C Reactive Protein can be falsely positive, there can be prolongation of antibiotic usage. Studies have shown that longer antibiotic usage can cause complications. Retrospective studies in very-low birth babies have shown higher mortality and Necrotising Enterocolitis in babies who have received more than 5 days antibiotics.
We propose that if sepsis screen is negative and the baby is well after 24 hours, antibiotics can be stopped if blood culture is negative. Neonates with suspected sepsis will be eligible for the trial if they become asymptomatic within 24 hours of starting antibiotics and fulfill inclusion and exclusion criteria. They will be randomized to either having a C Reactive protein done or no further testing. For the group that has no further testing, antibiotics will be stopped if blood culture is negative at 72 hours. For the group that has C Reactive protein done, antibiotics will be stopped when c Reactive protein is negative. Symptoms of sepsis will be monitored at 15 and 28 days after onset of initial symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Month(s)（—）
- 性别
- All
入选标准
- •1 Symptoms criteria a Apnea b Hyperthermia c Respiratory distress d Poor feeding e Lethargy f Irritability g Hypothermia h Hypotension i Poor perfusion j vomiting k Feed intolerance l Diarrhea m Seizures n Cyanosis 2 Laboratory criteria a Have a total WBC count more than 5000 per cubic millimeter b Have an Absolute Neutrophil Count more than 1500 per cubic millimeter 3 Baby becomes asymptomatic and are clinically well within 24 hours of suspicion of sepsis with following criteria a Normal activity b Stable temperature c Stable hemodynamic status with no need for inotropes d No respiratory support needed like supplementary oxygen CPAP ventilation.
排除标准
- •1 They have received antibiotics in the past 15 days 2 They have had surgery in the past 7 days 3 Total WBC count less than 5000 per cubic millimeter 4 Have an Absolute Neutrophil Count less than 1500 per cubic millimeter 5 Abnormal activity beyond 24 hours of suspicion of sepsis 6 Unstable temperature beyond 24 hours of suspicion of sepsis 7 Unstable hemodynamic status requiring inotropes 8 Respiratory support needed like supplementary oxygen CPAP ventilation.
结局指标
主要结局
All babies will be clinically reviewed 15 days after stopping antibiotics to look for any evidence of suspected sepsis
时间窗: 15 days after stopping antibiotics
Rates of restarting antibiotics for suspected sepsis within 15 days of stopping antibiotics in the two groups will be compared
时间窗: 15 days after stopping antibiotics
If babies have been discharged then this will be done over the phone with parents
时间窗: 15 days after stopping antibiotics
This will be also done in Out Patient Department for babies discharged or in the ward if still admitted
时间窗: 15 days after stopping antibiotics
次要结局
- Duration of antibiotic therapy(Incidence of necrotizing enterocolitis within 28 days of stopping antibiotics)