Perfusion Index Variability in Preterm Infants Treated With Two Different Natural Surfactants for Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 主要终点
- perfusion index
研究概览
简要总结
Perfusion index may vary according to type of surfactant during the treatment of respiratory distress syndrome.
详细描述
Peripheral tissues of preterm infants are very sensitive for hypoperfusion, but there are rare data in the literature for peripheral perfusion after surfactant treatment. In this study the investigators aimed to compare the perfusion index (PI) variability in premature infants with respiratory distress (RDS) following instillation of one of two different natural surfactant preparations.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •premature infants < 32 weeks of gestational age
排除标准
- •congenital malformation
- •Apgar scores <3 at 5 min
研究组 & 干预措施
Beractant
Beractant;bovine lung extract; both initial and subsequent dosing is 100 mg/kg (4 mL/kg), which may be given every 6 hours up to four total doses
干预措施: Beractant (Drug)
Poractant alfa
Poractant alfa; porcine lung extract; initial dosing is 200 mg/kg (2.5 mL/kg) and repeated dosing is given at 100 mg/kg (1.25 mL/kg) every 12 hours, up to maximum of two additional doses when indicated
干预措施: Poractant alfa (Drug)
结局指标
主要结局
perfusion index
时间窗: 1 week
PI and oxygen saturation (SpO2) were measured by "Masimo Rainbow SET Radical-7 pulse oximeter" before and after surfactant. The effects of the two treatment regimens on PI, oxygenation and clinical outcome were compared.
次要结局
- Duration of mechanical ventilation(4 weeks)
研究者
Dilek Dilli
Assos Prof
Dr. Sami Ulus Children's Hospital