Oxygen Exposure During Newborn Resuscitation and Pulmonary Oxidative Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- protein carbonyl concentration in the tracheal aspirate on day 1
研究概览
简要总结
Hypothesis: In this feasibility study, hyperoxemia, as approximated by transcutaneous hemoglobin saturation with oxygen (Sp02), at the time of birth will cause sustained pulmonary oxidative stress as demonstrated by elevation of pulmonary protein carbonyl. Furthermore, this oxidative stress will be directly proportional to the imposed oxygen-burden during resuscitation at the time of birth.
This study will give us information regarding the magnitude of protein carbonyl elevation in the preterm infant. With these results we will be able to 1. establish the technique for the running or protein carbonyl assays and 2. calculate an appropriate sample size for a future randomized control trial.
详细描述
Immediately prior to birth, preterm infants (<= 32 weeks gestation) will be randomized to one of three groups: 1. Low Oxygen Burden (LOB) - initiation of resuscitation with 21% 02, II. Moderate Oxygen Burden (MOB) - initiation of resuscitation with 100% 02 and III. High Oxygen Burden (HOB) - 100% 02 used for the entire resuscitation. A pulse oximetry monitor will be connected to a probe on the infant's hand to measure the transcutaneous hemoglobin saturation with oxygen (Sp02). Adjustments to the inspired oxygen concentration will be made every 15 seconds for infants in the LOB and MOB groups to achieve a target Sp02 range of 85-92%. Resuscitation will otherwise proceed as per standard of care. The intervention will end upon arrival in the neonatal intensive care unit.
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
- Double
入排标准
- 年龄范围
- 23 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<=32 weeks gestation
- •require intubation
排除标准
- •lethal anomalies
- •cyanotic congenital heart disease
- •known hemoglobinopathy
- •risk factors for persistent pulmonary hypertension
结局指标
主要结局
protein carbonyl concentration in the tracheal aspirate on day 1
次要结局
- protein carbonyl concentration in the tracheal aspirate on day 3
- protein carbonyl concentration in the tracheal aspirate on day 7
- protein carbonyl concentration in the tracheal aspirate on day 14
- protein carbonyl concentration in the tracheal aspirate on day 21
- protein carbonyl concentration in the tracheal aspirate on day 28