Pulse Oximetry With Clinical Observation to Screen for Lung Disease in Neonates
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15,000
- 主要终点
- pulse oximetry with clinical observation screen lung disease sensitivity
研究概览
简要总结
The investigator assessed the feasibility and reliability of pulse oximetry plus clinical observation for detection the lung disease in neonates.
详细描述
At present respiratory disease(RDS) diagnose base on clinical symptom and chest X-ray.But in china, because of the difference of medical conditions, some areas especially the basic level hospitals without the condition of X-ray examination, which can not be clearly diagnosed RDS.In 2013, the scholars analyzed the disease of neonatal intensive care unit (NICU) need to be exposed to radiation, and RDS was in the first place. There is no conclusion whether it bad for newborn to exposure more. But in animal models, there is a correlation between exposure to radiation and cancer.
Hyaline membrane disease(HMD) is common occur in preterm infants .pulmonary surfactant(PS) is a safe and effective treatment for neonatalHMD.Bahadue F L meta analyse conclusion is early application of PS is more benefit for HMD.
So investigator hypothesize that pulse oximetry with clinical assessment have high sensitivity,specificity ,positive and negative predictive value to lung disease.The aim is to reduce radiation exposure to neonate and to preterm infants with RDS can early application of PS.
Symptomatic definition:with grunting,nasal flaring,retraction,cyanosis,tachypnea,stridor.
Pulse oximetry positive criteria:1.atrial oxygen saturation (SpO2)<90%;2.heart rate>180 or <100 per minute.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 3 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestation age :28 to 42 weeks
- •birth weight :1000-4000g
- •asymptomatic or symptomatic respiratory symptom
排除标准
- •gestation age <28 weeks or >42 weeks
- •birth weight <1000g or >4000g
- •critical and serious heart disease
- •congenital malformation
结局指标
主要结局
pulse oximetry with clinical observation screen lung disease sensitivity
时间窗: 7 days
use wilson method to calculate the sensitivity
次要结局
- pulse oximetry with clinical observation screen lung disease specificity(7 days)
- pulse oximetry with clinical observation screen lung disease positive and negative value(7 days)
研究者
yangjie
professor
Guangdong Women and Children Hospital
