Comparative Trial of Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams
试验速览
- 阶段
- 4 期
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- The need of intubation and surfactant administration.
研究概览
简要总结
The purpose of this study is to compare two different treatment strategies for RDS in preterm infants > 1500 grams and evaluate whether a selective surfactant administration would reduce the need of intubation, mechanical ventilation and surfactant use.
详细描述
Respiratory Distress Syndrome (RDS) is a frequent respiratory problem of preterm infants and an important cause of morbidity and mortality.
The management of this disease usually includes intubation, surfactant administration and mechanical ventilation in infants less than 1500 grams. However, in patients over this weight, the treatment has not been standardized and depends on the clinical progression of oxygen requirements.
Hypothesis:
- Early CPAP and selective surfactant administration is an effective treatment for RDS in infants >1500 g. This could decrease or avoid intubation and surfactant administration.
Comparison(s):
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
- 5 Minutes 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth Weight > 1500 g.
- •First day of life.
- •Clinical and radiological signs of RDS.
- •Oxygen requirement over 30% to reach an oxygen saturation of 88%.
- •Parent's consent approved.
排除标准
- •Neonatal asphyxia, 5 minute Apgar < 3 or cord pH <7.
- •Cardiac or respiratory malformation.
- •Chromosomal disease.
- •Significative pneumothorax.
结局指标
主要结局
The need of intubation and surfactant administration.
次要结局
- Mechanical ventilation and CPAP duration.
- Oxygen therapy.
- BPD incidence.
- Length of stay.
- Enteral feeding tolerance.
- Air leak.
- NEC, gastric perforation.
- Death.