A Clinical Trial Comparing Surfactant Administration Through Supraglottic Airway or Thin Catheter for Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Combined bradycardia (heart rate < 100 for > 10 seconds) and hypoxemia (SpO2 < 80% for > 30 seconds) during surfactant administration
研究概览
简要总结
What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better. Surfactant can be given using a thin tube ("Less Invasive Surfactant Administration", called the LISA method) or through a small airway device placed in the baby's throat above the vocal cords ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for preterm infants who are born at 29-36 weeks of pregnancy and have trouble breathing.
What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer heart rate and breathing-related problems than those who receive it using the LISA method.
What are the aims? Aim 1: Are babies in the SALSA group less likely to have low heart rate or low oxygen levels during the procedure compared to babies in the LISA group? Aim 2: Do fewer babies in the SALSA group need to be put on a breathing machine within the first 72 hours of life? Aim 3: Does the SALSA method help reduce the overall time babies need breathing support and lower the cost of their care in the NICU?
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All preterm infants born between 29-36 weeks' gestation.
- •Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support requiring at least FiO2 25% and qualify for LISA procedure
排除标准
- •Infants who require intubation prior to surfactant therapy
- •Infants with known severe congenital anomalies (complex congenital heart disease, airway and central nervous system anomalies)
- •Infants whose birth weight is less than 750 grams or oropharynx unable to accommodate laryngeal mask airways
研究组 & 干预措施
Surfactant Administration through Thin Catheter
干预措施: Surfactant Administration through Thin Catheter (Procedure)
Surfactant Administration through Laryngeal or Supraglottic Airway
干预措施: Surfactant Administration through Laryngeal or Supraglottic Airway (Procedure)
结局指标
主要结局
Combined bradycardia (heart rate < 100 for > 10 seconds) and hypoxemia (SpO2 < 80% for > 30 seconds) during surfactant administration
时间窗: Time of laryngoscope or supraglottic airway device insertion to removal of device
* Bradycardia: defined as heart rate \< 100 beats per minute for \> 10 seconds. Heart rate will be obtained from participant's heart rate monitor. * Hypoxemia: oxygen saturation (SpO2) =\< 80% for \> 30 seconds. Oxygen saturation will be obtained from participant's pulse oximeter monitor * Events will be recorded by bedside respiratory therapy and/or bedside nurse during the procedure
次要结局
- Mean number of attempts required(At time of surfactant administration)
- Procedural success rate on first attempt(At time of surfactant administration procedure)
- Intubation rate(From time of procedure to 72 hours of life)
- Total duration of CPAP and mechanical ventilation days(Up to 52 weeks)
研究者
Melody Chiu
Assistant Professor of Pediatrics
University of Texas Southwestern Medical Center