Chorioamnionitis: Observation of at Risk Infants vs Standard Care. Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Sepsis-related signs and symptoms
研究概览
简要总结
This study evaluates the non-inferiority of a protocol of limited evaluation (complete blood count, blood culture) and clinical observation by standardized physical examination versus the algorithm suggested in the CDC's 2010 guidelines (limited evaluation, clinical observation and antibiotic therapy) in the management of asymptomatic infants born at term to mothers with suspected chorioamnionitis. The primary outcome of the study is the difference in the prevalence of sepsis-related symptoms between the two groups.
详细描述
Chorioamnionitis complicates 1-3% of pregnancies at term. The current international guidelines of the Center for Disease Control (CDC 2010) recommend that all asymptomatic newborns born to mothers with suspected chorioamnionitis undergo limited evaluation (i.e. blood culture at birth and complete blood count) and antibiotic therapy until the blood culture result is available.
However, the prevalence of positive blood cultures in infants born to mothers with suspected chorioamnionitis is low, approximately 1%, including also infants requiring intensive care. This prevalence is even lower in asymptomatic infants. Moreover, the efficacy of antibiotic prophylaxis in preventing early sepsis, death or long-term sequelae in asymptomatic infants born to mothers with suspected chorioamnionitis has not been demonstrated.
Early antibiotic use has been related to obesity and to the modification of microbiota. Limiting antibiotic use may prevent the emergence of antibiotic-resistant bacteria.
Clinical observation is a reliable method to recognize infants with sepsis.
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
- 10 Minutes 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •asymptomatic newborns born at term (>= 37 weeks of gestational age)
排除标准
- •preterm newborns (< 37 weeks gestational age)
- •sepsis-related signs of symptoms at birth
- •intensive care admittance
研究组 & 干预措施
Clinical observation
Asymptomatic newborns born at term to mothers with suspected chorioamnionitis. They will receive a limited evaluation (blood culture, complete blood count), and a clinical observation. Antibiotics will be started only if sepsis-related signs or symptoms are present.
干预措施: Clinical observation (Other)
Standard management
Asymptomatic newborns born at term to mothers with suspected chorioamnionitis. The will receive a limited evaluation (blood culture, complete blood count), a clinical observation and antibiotics at birth.
干预措施: Standard management (Other)
Standard management
Asymptomatic newborns born at term to mothers with suspected chorioamnionitis. The will receive a limited evaluation (blood culture, complete blood count), a clinical observation and antibiotics at birth.
干预措施: Clinical observation (Other)
结局指标
主要结局
Sepsis-related signs and symptoms
时间窗: 48 hours of life
Presence of pale/cyanotic/mottled skin, respiratory rate higher than 60 breaths/minute or respiratory distress
次要结局
- Mortality(21 days)
- Neonatal intensive care unit admittance(21 days)
- Days of antibiotics(21 days)
- Days of hospitalization(21 days)
研究者
Luca Ronfani
MD, PhD
IRCCS Burlo Garofolo