Surfactant Prophylaxis in LAte Preterm to Early Term Infants Using a Supraglottic Airway Device to Help Improve Outcomes
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 422
- 试验地点
- 6
- 主要终点
- Difference in Ranked Composite of Morbidities
研究概览
简要总结
The purpose of this research is to learn new information that may help other infants that have respiratory distress syndrome and need breathing support after birth. The goal of this research is to see if continuous positive airway pressure (CPAP) alone or CPAP with surfactant administration through a less invasive method via an Airway Device (supraglottic airway device) temporarily placed above the vocal cords is better for treating respiratory distress syndrome in late preterm and early term infants.
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
- 33 Weeks 至 38 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns 33-38+6 weeks gestation at birth
- •≤ 6 hours old
- •Respiratory Distress: [Silverman Andersen Score (SAS) ≥ 5, or Respiratory Severity Score (RSS) ≥ 1.25]
- •Clinical decision for non-invasive respiratory support
- •Written parental consent
排除标准
- •Surrogate deliveries
- •Major congenital or chromosomal anomalies
- •Prior intubation or receipt of surfactant
- •Known or suspected hypoxic ischemic encephalopathy (HIE)
- •Known or suspected neuromuscular disorder
- •Unanticipated survival
研究组 & 干预措施
Prophylactic Surfactant
A single dose of surfactant (Curosurf) will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). Infants who receive SALSA will remain on non-invasive respiratory support (Continuous Positive Airway Pressure).
干预措施: Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA) (Procedure)
Expectant Management (CPAP)
For participating infants randomly assigned to receive continuation of non-invasive respiratory support, they will remain on continuous positive airway pressure (CPAP).
干预措施: Continuous Positive Airway Pressure (CPAP) (Procedure)
结局指标
主要结局
Difference in Ranked Composite of Morbidities
时间窗: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Determine if there is a difference in ranked composite of morbidities including death, development of pneumothorax/ pulmonary air leaks, Respiratory Severity Score (RSS), time to initial feeding, and LOS (length of hospital stay) between the treatment and control groups using a linked count of participants who fall within each prespecified rank.
次要结局
- Length of Hospital Stay(From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.)
研究者
Anup Katheria, M.D.
Principal Investigator
Sharp HealthCare