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临床试验/NCT02533583
NCT02533583Unknown不适用

Pulse Oximetry With Clinical Observation to Screen for Lung Disease in Neonates

Guangdong Women and Children Hospital0 个研究点目标入组 15,000 人开始时间: 2015年11月最近更新:
适应症

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

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

发起方
Guangdong Women and Children Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

yangjie

professor

Guangdong Women and Children Hospital

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