Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- oxidative stress status
研究概览
简要总结
In this randomized control trial, the investigators hypothesize that late-preterm infants resuscitated with a "low oxygen delivery" strategy (initiation of resuscitation with room air) will result in a significant reduction in oxidant stress without any harmful clinical effects.
详细描述
The delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Some studies have shown that resuscitation of term newborn infants with room air were safe and of great benefit. A static room air, however, may be inappropriate for resuscitation of preterm infants. The number of late-preterm infants has increased in recent years, which represent approximately 70% of all preterm infants. Our study will evaluate the safety and efficacy of using room air during resuscitation of late-preterm infants and whether this will avoid oxidative stress derived damage and improve outcomes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 34 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inborn infant
- •gestation 34 weeks to 36 weeks 6 days
排除标准
- •known chromosomal or congenital anomalies
结局指标
主要结局
oxidative stress status
时间窗: 7 days
oxygen saturations
时间窗: 10 min
次要结局
- Necrotizing Enterocolitis(28 days)
- Retinopathy of prematurity(28 days)
- Days on oxygen(28 days)
- Intracranial hemorrhage(28 days)
- Days on conventional ventilation(28 days)
- Days on nasal canula(28 days)
- Pneumothorax(28 days)
- Days on high frequency ventilation(28 days)
- Oxygen requirement(At 36 weeks adjusted age)
- Hypoxic ischemic encephalopathy(28 days)
- Patent ductus arteriosus(28 days)
- Death(28 days)
研究者
Zhangbin Yu
Director
Nanjing Medical University