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

Guangdong Women and Children Hospital

Status: Unknown

Conditions: Lung Diseases

Treatments: Device: pulse oximetry (PHILIPS intelliven MP5)

Study type: Observational

Funder types: Other

Identifiers

NCT02533583

guangdongwchhi1

Details and patient eligibility

About

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

Full description

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.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 1 to 3 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. gestation age :28 to 42 weeks
2. birth weight :1000-4000g
3. asymptomatic or symptomatic respiratory symptom

Exclusion criteria

1. gestation age <28 weeks or >42 weeks
2. birth weight <1000g or >4000g
3. critical and serious heart disease
4. congenital malformation

Trial design

15,000 participants in 2 patient groups

symptomatic newborn

Description:

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.

Treatment:

Device: pulse oximetry (PHILIPS intelliven MP5)

Asymptomatic newborn

Description:

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.

Treatment:

Device: pulse oximetry (PHILIPS intelliven MP5)