Less Invasive Beractant Administration in Preterm Infants: a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- % patients >1 h of mechanical ventilation
研究概览
简要总结
The aim of this study is to assess the efficacy and feasibility of a new less invasive surfactant administration (LISA) technique with a specific designed cannula for surfactant administration using Beractant replacement in preterm infants <32 weeks of gestation and compare short and long term outcomes with the intubation, administration of surfactant and extubation method (INSURE).
This was a single-center, prospective, open-label, non-randomized, controlled study with an experimental cohort of 30 patients treated with LISA and a retrospective control group comprising the 30 most recently treated patients with INSURE. Beractant (4 ml/Kg) was administered as exogenous surfactant in both groups if patients on nasal continuous positive airway pressure (nCPAP) during the first three days of life were needed of more than 30% of fraction of inspired oxygen inspired oxygen fraction (FiO2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants of less than 32 weeks of gestation (WG)breathing spontaneously on nCPAP during the first three days of life that met exogenous surfactant administration criteria (Table l) were eligible to enroll in the study
排除标准
- •Infants who met intubation criteria (Table 1) at the moment of the surfactant administration were excluded in both groups.
结局指标
主要结局
% patients >1 h of mechanical ventilation
时间窗: through study completion, an average of 1 year
The percentage of patients that required more than 1 hour of mechanical ventilation during the first three days of age.
次要结局
- need for intermittent mechanical ventilation (iMV)(through study completion, an average of 1 year)
- second dose of surfactant(through study completion, an average of 1 year)
- attempts to catheterize(through study completion, an average of 1 year)
- bradycardia episodes(through study completion, an average of 1 year)
- surfactant reflux cases(through study completion, an average of 1 year)
研究者
Manuel Sanchez Luna
Dr
Hospital General Universitario Gregorio Marañon