Less Invasive Surfactant Administration in Nigeria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 6
- 主要终点
- 72-hour mortality
研究概览
简要总结
Implement surfactant (BLES®) replacement therapy using the Less Invasive Surfactant Administration technique in six tertiary institutions in Nigeria and evaluate its impact on 72-hour neonatal mortality in premature infants born less than 2000 grams at birth.
详细描述
Background: In low- and middle-income countries (LMICs), respiratory distress syndrome (RDS) accounts for ~45% of all in-hospital neonatal mortality. Surfactant use is limited in LMICs, in part, due to the high cost, the lack of skill to perform laryngoscopy and tracheal intubation, and perhaps a perception that surfactant administration and mechanical ventilation must occur together. In LMICs, continuous positive airway pressure (CPAP) is often the highest mode of respiratory support available, and CPAP failure invariably means death. If Less Invasive Surfactant Administration (LISA) can reduce CPAP failure, as shown in high-income settings, it potentially can reduce prematurity-related neonatal mortality in LMICs. There are, however, no studies on how to safely implement LISA in LMICs. The LISA procedure is novel in LMICs; the procedure is not without risk (severe and minor), laryngoscopy is a difficult skill to acquire, master, and maintain, and the resource limitations in LMICs need consideration while implementing LISA.
Hypothesis: Compared to a historical control, introducing non-invasive surfactant administration through the less invasive surfactant administration (LISA) techniques will result in a relative risk reduction of all-cause 72-hour in-hospital mortality by at least 20%.
PICO Outline:
Population: Preterm infants </= 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of >4, who are spontaneously breathing, and on CPAP.
Intervention: Surfactant administered through the less invasive surfactant administration (LISA), technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns with birth weight between 500-2000 grams (determined by birth weight or admission weight if birth weight is unavailable).
- •≤48 Hours old at recruitment.
- •Spontaneously breathing but have clinical signs of respiratory distress (defined by Anderson Silverman Score (ASS) ≥4 (range 0-10)) and on CPAP.
- •Admitted to the neonatal/newborn units (or special care nurseries).
排除标准
- •Any newborn intubated before admission to the neonatal/newborn units.
- •Any newborn infants with a significant congenital abnormality
- •Any preterm infant considered nonviable by the managing clinician.
研究组 & 干预措施
LISA Arm
Eligible subjects who have respiratory distress syndrome (Anderson Silverman Score >4) managed on continuous positive airway pressure (CPAP) will receive surfactant via a thin catheter while on CPAP.
干预措施: Surfactant (Drug)
结局指标
主要结局
72-hour mortality
时间窗: 72 hours of life
All cause mortality with 72-hours of life
次要结局
- In-hospital mortality(Through hospitalization, an average of 1 day to 10 weeks.)
- Difference in RDS score before and after the procedure.(6 hours post procedure)
研究者
Osayame Ekhaguere
Assistant Professor of Pediatrics
Indiana University