Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS), Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Rate of culture-proven sepsis in the blood or CSF
研究概览
简要总结
The OMEPS trial is a randomized clinical trial in the western region of Saudi Arabia. Conducted to assess the safety and feasibility of olive oil as massage for preterm infants and if associated with reduced risk of Late-Onset 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
- 24 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born at one of the participated centers.
- •Preterm Infants born at ≥24weeks gestation and ≤32weeks gestation
- •Birth weight ≥ 500gm up to 2000 gm.
排除标准
- •Outborn Infants.
- •Preterm infants < 24wk or > 32 wk
- •Preterm infants < 500 gm or > 2000gm
- •Critically ill patients, e.g., Hemodynamic unstable, culture-confirmed neonatal sepsis, Hydrops fetalis, Life-threatening congenital anomalies.
- •Congenital skin anomalies or infection
- •Major surgical procedure
- •Any patient whose parents refuse consent.
- •Death within 48 hours of life.
研究组 & 干预措施
Study
The olive oil massage will be applied initially at 72 hrs of life then twice daily with a dose of 4ml/kg till 28 days .
干预措施: Olive Oil Massage (Biological)
Control
Patients who are assigned to the control group will receive standard care as per unit policies.
结局指标
主要结局
Rate of culture-proven sepsis in the blood or CSF
时间窗: 72 hours from birth till 28 days of life
Primary outcomes defined as the rate of culture-proven sepsis in the blood or CSF in the 28 days of life.Late-onset sepsis defined as sepsis onset after 72 h of life. The olive oil will be applied initially at 72 hours of life then twice daily with a dose of 4ml/kg.
次要结局
- Neonatal Skin Condition score(72 hours from birth till 28 days of life)