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

August 11, 2016 updated by: yangjie, Guangdong Women and Children Hospital
The investigator assessed the feasibility and reliability of pulse oximetry plus clinical observation for detection the lung disease in neonates.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

15000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All infants will born in guangdong women and children hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • PHILIPS intelliven MP5

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Women and Children Hospital

Investigators

  • Study Chair: jie yang, doctor, Guangdong Women and Children Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • guangdongwchhi1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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