Multicenter Randomized Controlled Trial Of Restrictive Fluid Management For Respiratory Distress in the Newborn Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Time from birth to first oral feeding
研究概览
简要总结
The object of this study is to determine the best way to care for infants with respiratory distress. The investigators are testing a method of feeding fluids to infants with respiratory distress in amounts similar to what healthy breastfed babies eat when they are feeding on demand, and comparing this method to the current standard of care for feeding fluids to infants with respiratory distress. These methods of feeding fluids to the study infants will continue until the infants are able to feed normally by mouth. The study will include about 400 infants across five sites in the United States, Chile and Argentina.
详细描述
Infants with respiratory distress syndrome will be enrolled within the first twelve hours of life, and randomly assigned to one of two groups: the first group will receive the interventional fluid management method, and the second (the control group) will receive the current standard of care for fluid management. To standardize respiratory care across all five study sites, a computer-based algorithm for respiratory support management based on objective markers of respiratory distress will guide clinician management decisions. However, each infant's medical team will make all final decisions on respiratory treatment and IV fluid management. Any study infant who experiences dehydration and/or low blood sugar during the course of the study will be removed from the study and be treated for the condition.
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
- — 至 12 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates born between 34-0/7 and 41-6/7 weeks gestational age (GA) at birth with primary pulmonary disease of the newborn including Transient Tachypnea of the Newborn (TTN), Respiratory Distress Syndrome (RDS), air leak syndrome, pneumonia, or meconium aspiration syndrome in the first 12 hours of life will be eligible for inclusion in this study.
- •Those neonates who are intubated for administration of exogenous surfactant but who are immediately extubated to non-invasive respiratory support after surfactant administration will remain eligible for study inclusion.
排除标准
- •Neonates with a genetic abnormality or congenital anatomic anomaly
- •Subsequent Study Exclusion resulting in removal from study:
- •Neonates who subsequently undergo endotracheal intubation and mechanical ventilation for refractory respiratory distress
- •Neonates with hypoglycemia or clinical evidence of dehydration or volume depletion requiring fluid bolus
- •Infants that are transported out of the participating site prior to study endpoint.
结局指标
主要结局
Time from birth to first oral feeding
时间窗: every 24 hours for up to 168 hours
Total Hours until first oral feeding
次要结局
- Duration of Respiratory Support(every 3 hours for up to 168 hours)
- Total Duration of NICU stay(every 24 hours up to 12 weeks)