Feasibility Study - Neofact Feasibility Study of the Application Aid Neofact (Formerly: QuickSF) in the Less Invasive Surfactant Administration (LISA) in Premature Infants With Respiratory Distress Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- feasibility of the application aid Neofact
研究概览
简要总结
For therapy of respiratory distress syndrome (RDS) in premature babies, there are several established options. An important therapeutic aspect is the tracheal administration of exogenous surfactant into the child's lung.
In the recent years, several methods have been developed. The methods differ in the selected ventilation mode (intubation with mechanical ventilation vs. Continous Positive Airway Pressure (CPAP)-supported spontaneous breathing) and in the way in which the application of surfactant is technically conducted (via endotracheal tube, endotracheal catheter or nebulization).
In selection of ventilation technique, there is an upcoming trend towards less invasive respiratory support via CPAP. While this may increase the rate of complications on the one side (i.e. pneumothorax), it shows much lower oxygen demand and a shorter need for mechanical ventilation on the other side.
In the selection of the administration technique, different methods were repeatedly developed to adapt the surfactant administration to the CPAP therapy. In this study, a newly developed and in the European Community now certified (CE-Mark) application aid (Neofact) will be tested for the first time on preterm infants, to verify the feasibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- — 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with respiratory distress syndrome and the need for Surfactant administration (oxygen requirement with FiO2 ≥ 30% and/or mod. Silverman Andersen Respiratory Severity Score (RSS) ≥ 5)
- •Respiratory support with non-invasive CPAP at the time of Surfactant administration
排除标准
- •Preterms with an gestational age < 26+0 weeks
- •Preterms with malformations of the respiratory tract
- •Clinical decision on intubation / surfactant application via endotracheal tube e.g. because of respiratory drive disorder
- •(Missing parental consent)
- •(Attending physician is not delegated by the principal investigator)
结局指标
主要结局
feasibility of the application aid Neofact
时间窗: Administration of surfactant + 30 minutes
Feasibility will be defined as a correct intratracheal position of the catheter (visually controlled via videolaryngoscope) OR responsiveness of the child to the surfactant administration (defined as decrease of the fraction of inspired oxygen (FiO2) of at least 0.05 within 30 minutes after the application OR FiO2 decrease to 0.21 with simultaneous improvement of the modified Silverman Andersen Respiratory Severity Score (RSS) ≥ 2 within 30 minutes after the application) without switching to a conventional LISA method RSS in the modified version of McAdams RM et al. The RSS consists of 5 categories that assess the respiratory work of the child in a range from 0 to 2 in each category. This results in a summarized score of 0 to 10, in which 0 defines a healthy neonate without increased work of breathing and 10 a neonate with maximum respiratory distress.
次要结局
- Duration of the surfactant administration procedure(up to 20 minutes)
- Need for intubation and mechanical ventilation(48 hours after administration)
- Number of attempts needed for the correct application(during application procedure)
- Occurrence of complications(during application procedure)
- Duration of the laryngoscopy(up to 15 minutes)
- Colonization of the catheter tip(up to 20 minutes)