Lung DiseasesNCT02533583
Pulse Oximetry With Clinical Observation to Screen for Lung Disease in Neonates
An observational study of Lung Diseases, run by Guangdong Women and Children Hospital.
Trial summary
The investigator assessed the feasibility and reliability of pulse oximetry plus clinical observation for detection the lung disease in neonates. Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Lung Diseases
- What is being tested?
- pulse oximetry (PHILIPS intelliven MP5)
- Type of treatment
- Medical device
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Study population: All infants will born in guangdong women and children hospital
Who may be able to join
- gestation age :28 to 42 weeks
- birth weight :1000-4000g
- asymptomatic or symptomatic respiratory symptom
Who cannot join
- gestation age <28 weeks or >42 weeks
- birth weight <1000g or >4000g
- critical and serious heart disease
- congenital malformation
About this study
The investigator assessed the feasibility and reliability of pulse oximetry plus clinical observation for detection the lung disease in neonates.
Read the 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.
- Conditions
- Lung Diseases
- Being tested
- pulse oximetry (PHILIPS intelliven MP5)
- Keywords
- pulse oximetry, clinical assessment, neonate, lung disease
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulse oximetry (PHILIPS intelliven MP5)Device
Also called PHILIPS intelliven MP5
all newborn monitor pulse oximetry in left hand
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: pulse oximetry (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. Receives: Device: pulse oximetry (PHILIPS intelliven MP5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse oximetry with clinical observation screen lung disease sensitivity
use wilson method to calculate the sensitivity
Measured: 7 days
Secondary outcomes (2)
pulse oximetry with clinical observation screen lung disease specificity
use wilson method to calculate the specificity
Measured: 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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yangjie, Guangdong Women and Children Hospital
- Investigators
- jie yang, doctor, Study chair, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533583
- Sponsor's protocol ID
- guangdongwchhi1
- Status last verified
- Aug 2016
- First submitted
- 4 Aug 2015
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhao QM, Ma XJ, Ge XL, Liu F, Yan WL, Wu L, Ye M, Liang XC, Zhang J, Gao Y, Jia B, Huang GY; Neonatal Congenital Heart Disease screening group. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54. doi: 10.1016/S0140-6736(14)60198-7. Epub 2014 Apr 22.
PubMed 24768155Iyer NP, Baumann A, Rzeszotarski MS, Ferguson RD, Mhanna MJ. Radiation exposure in extremely low birth weight infants during their neonatal intensive care unit stay. World J Pediatr. 2013 May;9(2):175-8. doi: 10.1007/s12519-013-0417-1. Epub 2013 May 16.
PubMed 23677834Bahadue FL, Soll R. Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD001456. doi: 10.1002/14651858.CD001456.pub2.
PubMed 23152207
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Oximetry With Clinical Observation to Screen for Lung Disease in Neonates
- ClinicalTrials.gov ID
- NCT02533583
- Acronym / sponsor ID
- guangdongwchhi1
- Conditions
- Lung Diseases
- Keywords
- pulse oximetry, clinical assessment, neonate, lung disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator assessed the feasibility and reliability of pulse oximetry plus clinical observation for detection the lung disease in neonates.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| symptomatic newborn | – | Device: pulse oximetry (PHILIPS intelliven MP5)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. |
| Asymptomatic newborn | – | Device: pulse oximetry (PHILIPS intelliven MP5)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. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All infants will born in guangdong women and children hospital
Key inclusion criteria (3 listed)
- gestation age :28 to 42 weeks
- birth weight :1000-4000g
- asymptomatic or symptomatic respiratory symptom
Key exclusion criteria (4 listed)
- gestation age <28 weeks or >42 weeks
- birth weight <1000g or >4000g
- critical and serious heart disease
- congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulse oximetry (PHILIPS intelliven MP5)Also: PHILIPS intelliven MP5all newborn monitor pulse oximetry in left hand | Device | Asymptomatic newborn, symptomatic newborn |
Primary outcome
pulse oximetry with clinical observation screen lung disease sensitivity
Time frame: 7 days
use wilson method to calculate the sensitivity
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Background: PubMed 24768155Zhao QM, Ma XJ, Ge XL, Liu F, Yan WL, Wu L, Ye M, Liang XC, Zhang J, Gao Y, Jia B, Huang GY; Neonatal Congenital Heart Disease screening group. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54. doi: 10.1016/S0140-6736(14)60198-7. Epub 2014 Apr 22.
- Background: PubMed 23677834Iyer NP, Baumann A, Rzeszotarski MS, Ferguson RD, Mhanna MJ. Radiation exposure in extremely low birth weight infants during their neonatal intensive care unit stay. World J Pediatr. 2013 May;9(2):175-8. doi: 10.1007/s12519-013-0417-1. Epub 2013 May 16.
- Background: PubMed 23152207Bahadue FL, Soll R. Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD001456. doi: 10.1002/14651858.CD001456.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jie yang, doctor study chair
Guangdong Women and Children Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by Guangdong Women and Children Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulse oximetry with clinical observation screen lung disease sensitivity (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02533583, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2016.