THE EFFECT OF SUSTAINED LUNG INFLATION MANEUVER APPLIED THROUGH NASAL PRONG ON EARLY AND LATE RESPIRATORY MORBIDITIES IN PRETERM INFANTS
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 250
- 主要终点
- mechanical ventilation requirement
研究概览
简要总结
Purpose: The investigators hypothesis is that, as compared to the only nCPAP-applied group, application of SLI maneuver followed by respiratory support with nCPAP immediately afterwards in preterm infants at high risk for RDS would reduce the need for intubation and mechanical ventilation in early period and ultimately will improve respiratory outcomes.
详细描述
Primary Outcome Measures:
Surfactant need, intubation and mechanical ventilation needs within the first 72 hours of life in SLI (Sustained Lung Inflation) maneuver-applied preterm infants and non-SLI-applied preterm infants.
Secondary Outcome Measures:
- Heart rate, fractional inspiratory oxygen, CPAP pressure and oxygen saturation within the first 72 hours of life in preterm infants
- Total non-invasive, invasive respiratory support time
- The presence of and the degree of BPD (Bronchopulmonary dysplasia)
- Premature morbidities such as PDA (patent ductus arteriosus), IVH (intraventricular hemorrhage), NEC (necrotizing enterocolitis), ROP (retinopathy of prematurity)
- Feeding intolerance, reaching birth weight and transition to full oral feeding time
Study Design Randomization Group 1: Group that received SLI maneuver immediately after birth followed by nCPAP.
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
- — 至 3 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days will be included.
排除标准
- •Presence of major congenital anomaly,
- •Patients with hydrops fetalis and pulmonary hypoplasia
- •Consent not provided or refused
结局指标
主要结局
mechanical ventilation requirement
时间窗: 72 hours
Surfactant requirement, intubation and mechanical ventilation needs within the first 72 hours of life in SLI (Sustained Lung Inflation) maneuver-applied preterm infants and non-SLI-applied preterm infants.
次要结局
未报告次要终点