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

NCT02533583 | Unknown

• 1 other identifier: guangdongwchhi1
• Study Type: observational
• Target: 15,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lung Diseases

Keywords

pulse oximetry; clinical assessment; neonate; lung disease

Outcome Measures

Primary Outcomes (1)

• pulse oximetry with clinical observation screen lung disease sensitivity

  use wilson method to calculate the sensitivity

  7 days

Secondary Outcomes (2)

• pulse oximetry with clinical observation screen lung disease specificity

  7 days

• pulse oximetry with clinical observation screen lung disease positive and negative value

  7 days

Study Arms (2)

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)

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)

Interventions

pulse oximetry (PHILIPS intelliven MP5) DEVICE

all newborn monitor pulse oximetry in left hand

Also known as: PHILIPS intelliven MP5

Asymptomatic newborn; symptomatic newborn

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All infants will born in guangdong women and children hospital

You may qualify if:

• gestation age :28 to 42 weeks
• birth weight :1000-4000g
• asymptomatic or symptomatic respiratory symptom

You may not qualify if:

• gestation age \<28 weeks or \>42 weeks
• birth weight \<1000g or \>4000g
• critical and serious heart disease
• congenital malformation

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

Related Publications (3)

• 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.

  PMID: 24768155 BACKGROUND

• Iyer 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.

  PMID: 23677834 BACKGROUND

• Bahadue 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.

  PMID: 23152207 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Interventions

Oximetry

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• jie yang, doctor

  Guangdong Women and Children Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 27, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 12, 2016

Record last verified: 2016-08