Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,512
- 试验地点
- 8
- 主要终点
- Hospital Survival
研究概览
简要总结
The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are:
Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique?
Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant.
Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will:
Receive surfactant replacement therapy by the less invasive surfactant administration technique.
Be monitored for complications Be followed throughout their hospitalization to determine their survival rate.
详细描述
The low- and middle-income countries of Sub-Saharan Africa (SSA) carry the highest burden of preterm births and deaths. A primary driver of preterm mortality in SSA is respiratory distress syndrome. Surfactant replacement therapy by the less invasive surfactant administration (LISA) is a technique where the surfactant is administered to a preterm neonate with respiratory distress syndrome managed on continuous positive airway pressure (CPAP), reducing the need for using an invasive mechanical ventilator. In high-income countries, LISA has been shown to be effective in reducing the need for invasive mechanical ventilators and mortality. However, the impact of LISA is unknown in low-resourced settings without ventilators.
The central hypothesis is that implementing LISA in newborn units that care for preterm neonates using standardized CPAP and caffeine citrate will improve survival in preterm neonates.
PICO Outline:
Population: Preterm neonates 750 and 2000 grams or gestational age between 24- and 35 weeks at birth with respiratory distress defined by a Silverman Anderson Score of ≥5, 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
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks.
- •Silverman Anderson Score ≥5 before or after CPAP treatment.
- •Admitted to a study site within 24 hours of life.
排除标准
- •Major congenital or genetic anomalies.
- •Active pulmonary hemorrhage.
- •Major craniofacial anomalies that preclude the successful use of CPAP
研究组 & 干预措施
LISA Group
Preterm infants with respiratory distress syndrome, who are on continuous positive airway pressure support are treated with caffeine citrate and surfactant through the less invasive surfactant administration technique.
干预措施: Surfactant (Drug)
结局指标
主要结局
Hospital Survival
时间窗: Through hospitalization, an average of 6 months
Survival to hospital discharge
次要结局
- The incidence of pneumothorax(Through hospitalization, an average of 6 months)
- Incidence of major preterm neonatal morbidity(Through hospitalization, an average of 6 months)
- Hospital survival at seven day(7 days following birth)
研究者
Osayame Ekhaguere
Assistant Professor of Pediatrics
Indiana University