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

Study Overview
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Brief Summary
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The investigator assessed the feasibility and reliability of pulse oximetry plus clinical observation for detection the lung disease in neonates.

Detailed Description
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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. Clinical assessment:1.respiratory physical examination:non-symmetry,decrease breathing sound,bubbles sound.2.Delivery history:caesarean,premature rupture of membranes,liquor,mother conditions,Apgar score. Congenital heart disease classification:1.critical:defects causing of the death or needing intervention before 28 days.2.serious:defects needing intervention before 1 year of age.significant:defects persisting longer than 6 months of age ,but not classified as critical or serious.4.non-significant:defects not physically appreciable and not persisting after 6 months of age.

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

Conditions
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Lung Diseases

Intervention / Treatment
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* Device: pulse oximetry (PHILIPS intelliven MP5)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gestation age :28 to 42 weeks birth weight :1000-4000g asymptomatic or symptomatic respiratory symptom Exclusion Criteria: gestation age <28 weeks or >42 weeks birth weight <1000g or >4000g critical and serious heart disease congenital malformation

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| symptomatic newborn<br>the symptomatic newborn cohort( symptomatic definition see detail),all of babies will referred for chest X-ray,and within 2 hours performing echocardiography to exclude critical and serious heart disease.All clinical assessment will do by attending doctor. | Device: pulse oximetry (PHILIPS intelliven MP5)<br>* all newborn monitor pulse oximetry in left hand<br>* Other names: PHILIPS intelliven MP5;|
| Asymptomatic newborn<br>the asymptomatic newborn cohort will gave pulse oximetry and clinical assessment every 8 hours within 3 days.everybody have positive results will been preformed chest X-ray and echocardiography.All clinical assessment will do by attending doctor. | Device: pulse oximetry (PHILIPS intelliven MP5)<br>* all newborn monitor pulse oximetry in left hand<br>* Other names: PHILIPS intelliven MP5;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulse oximetry with clinical observation screen lung disease sensitivity | use wilson method to calculate the sensitivity | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulse oximetry with clinical observation screen lung disease specificity | use wilson method to calculate the specificity | 7 days | 
| pulse oximetry with clinical observation screen lung disease positive and negative value | use logistic regression model wo calculate the accuracy of the method | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulse oximetry, clinical assessment, neonate, lung disease