Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 7
- 主要终点
- Need for Intubation and Mechanical Ventilation in the First Seven Days of Life.
研究概览
简要总结
The primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive surfactant.
详细描述
Secondary outcomes were total number of hours on mechanical ventilation, CPAP and supplemental oxygen during the first 7 days of life and for the entire hospitalization. Other secondary outcomes were number of surfactant doses, incidence of pulmonary air leak, survival until discharge, chronic lung disease (defined as need for oxygen at 36 weeks PMA), oxygen requirement at discharge, severe intraventricular hemorrhage (Grade 3/4), and periventricular leukomalacia.
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
- None
入排标准
- 年龄范围
- — 至 36 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at time of enrollment 28 0/7 to 35 6/7 weeks postmenstrual age
- •Age less than or equal to 36 hours old
- •On nCPAP 6 with supplemental oxygen requirement (Fi02 greater than or equal to 30%) for greater than or equal to 30 minutes (to maintain Sa02 between 88-92%)
- •Chest radiograph and clinical presentation consistent with respiratory distress syndrome (tachypnea, retractions, nasal flaring, and/or grunting
排除标准
- •Prior mechanical ventilation or surfactant administration
- •Major congenital anomaly
- •Abnormality of the airway
- •Respiratory distress secondary to an etiology other than respiratory distress syndrome (pneumothorax, meconium aspiration syndrome, pneumonia, hypoxic-ischemic encephalopathy)
- •Apgar score < 5 at 5 minutes of age
研究组 & 干预措施
nCPAP Control Group
Infants in the Control Group were maintained continuously on nasal CPAP 6 cm H2O with no surfactant administered.
干预措施: Nasal continuous positive airway pressure (nCPAP) (Device)
LMA Group
Once proper placement of the LMA was achieved, surfactant (Curosurf®, 2.5 ml/kg, Chiesi USA, Inc., Cary, NC) was administered. The LMA cuff was then deflated, LMA removed and the infant placed back on nasal CPAP 6 cm H2O.
干预措施: Nasal continuous positive airway pressure (nCPAP) (Device)
LMA Group
Once proper placement of the LMA was achieved, surfactant (Curosurf®, 2.5 ml/kg, Chiesi USA, Inc., Cary, NC) was administered. The LMA cuff was then deflated, LMA removed and the infant placed back on nasal CPAP 6 cm H2O.
干预措施: Laryngeal Mask Airway (LMA) to deliver surfactant (Device)
LMA Group
Once proper placement of the LMA was achieved, surfactant (Curosurf®, 2.5 ml/kg, Chiesi USA, Inc., Cary, NC) was administered. The LMA cuff was then deflated, LMA removed and the infant placed back on nasal CPAP 6 cm H2O.
干预措施: Surfactants, Pulmonary (Drug)
结局指标
主要结局
Need for Intubation and Mechanical Ventilation in the First Seven Days of Life.
时间窗: Seven days
"Treatment Failure" criteria were the same for both groups. "Treatment Failure" required two of the following: 1) FiO2 \>40% for longer than 30 minutes (to maintain SaO2 88-92%), 2) PCO2 \>65mmHg on ABG/CBG or \>70 on VBG, or 3) pH\<7.22 on ABG/CBG/VBG or one of the following: 1) recurrent or severe apnea, 2) hemodynamic instability requiring pressors, 3) repeat surfactant dose at appropriate time with FiO2 \>40%, or 4) deemed necessary by medical provider.
次要结局
- Duration of CPAP Therapy(During first seven days of life)
- Incidence of Severe IVH or PVL(During hospitalization)
- Duration of Oxygen Therapy(During first seven days of life)
- Incidence of Pulmonary Airleaks(First 7 days of life)
- Incidence of Chronic Lung Disease(Measured at hospital discharge)