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

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ClinicalTrials.gov Identifier: NCT02533583
Recruitment Status : Unknown
Verified August 2016 by yangjie, Guangdong Women and Children Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2015
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
yangjie, Guangdong Women and Children Hospital

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

Condition or disease Intervention/treatment
Lung Diseases Device: pulse oximetry (PHILIPS intelliven MP5)

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Pulse Oximetry With Clinical Observation to Screen for Lung Disease in Neonates
Study Start Date : November 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Group/Cohort Intervention/treatment
symptomatic newborn
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)
all newborn monitor pulse oximetry in left hand
Other Name: PHILIPS intelliven MP5

Asymptomatic newborn
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)
all newborn monitor pulse oximetry in left hand
Other Name: PHILIPS intelliven MP5




Primary Outcome Measures :
  1. pulse oximetry with clinical observation screen lung disease sensitivity [ Time Frame: 7 days ]
    use wilson method to calculate the sensitivity


Secondary Outcome Measures :
  1. pulse oximetry with clinical observation screen lung disease specificity [ Time Frame: 7 days ]
    use wilson method to calculate the specificity

  2. pulse oximetry with clinical observation screen lung disease positive and negative value [ Time Frame: 7 days ]
    use logistic regression model wo calculate the accuracy of the method



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All infants will born in guangdong women and children hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533583


Sponsors and Collaborators
Guangdong Women and Children Hospital
Investigators
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Study Chair: jie yang, doctor Guangdong Women and Children Hospital

Publications:
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Responsible Party: yangjie, professor, Guangdong Women and Children Hospital
ClinicalTrials.gov Identifier: NCT02533583    
Other Study ID Numbers: guangdongwchhi1
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Keywords provided by yangjie, Guangdong Women and Children Hospital:
pulse oximetry
clinical assessment
neonate
lung disease
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases