Meconium Aspiration Syndrome and Non-vigorous Neonates-Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Ability to identify, consent, enroll and randomize 70% of eligible infants into study.
研究概览
简要总结
Feasibility study to randomize non-vigorous newborn infants born through meconium-stained amniotic fluid to endotracheal suctioning or immediate resuscitation.
详细描述
This will be a pilot feasibility trial of endotracheal intubation and suctioning versus routine resuscitation for term, non-vigorous newborns born through meconium-stained amniotic fluid to compare the incidence of meconium aspiration syndrome, extracorporeal membrane oxygenation or death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 5 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term newborns (>37 weeks of gestation)
- •Delivery through meconium-stained amniotic fluid
- •Mothers >18 years of age
排除标准
- •No consent from mother
- •Infant vigor at delivery (muscle tone and respiratory effort)
- •Prenatally diagnosed major anomalies (excluding gastroschisis)
- •Plan to not resuscitate infant
- •Family does not speak English
研究组 & 干预措施
Immediate intubation
These infants will have immediate endotracheal suctioning after delivery. They will then have resuscitation per Neonatal Resuscitation Program guidelines.
干预措施: Immediate intubation (Procedure)
Immediate resuscitation
These infants will have immediate resuscitation per the Neonatal Resuscitation Program guidelines without endotracheal suctioning.
干预措施: Immediate resuscitation (Procedure)
结局指标
主要结局
Ability to identify, consent, enroll and randomize 70% of eligible infants into study.
时间窗: 18 months
Feasibility measures
The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die
时间窗: 18 months
Clinical outcome measure
次要结局
未报告次要终点
研究者
Marya Strand, MD
Associate Professor of Pediatrics
St. Louis University