Overview

This trial is active, not recruiting.

Condition lung diseases
Treatment pulse oximetry (philips intelliven mp5)
Sponsor Guangdong Women and Children's Hospital and Health Institute
Start date November 2015
End date November 2016
Trial size 15000 participants
Trial identifier NCT02533583, guangdongwchhi1

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-crossover
Time perspective prospective
Arm
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.
pulse oximetry (philips intelliven mp5) PHILIPS intelliven MP5
all newborn monitor pulse oximetry in left hand
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.
pulse oximetry (philips intelliven mp5) PHILIPS intelliven MP5
all newborn monitor pulse oximetry in left hand

Primary Outcomes

Measure
pulse oximetry with clinical observation screen lung disease sensitivity
time frame: 7 days

Secondary Outcomes

Measure
pulse oximetry with clinical observation screen lung disease specificity
time frame: 7 days
pulse oximetry with clinical observation screen lung disease positive and negative value
time frame: 7 days

Eligibility Criteria

Male or female participants up to 3 days old.

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

Additional Information

Official title Pulse Oximetry With Clinical Observation to Screen for Lung Disease in Neonates
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Guangdong Women and Children's Hospital and Health Institute.