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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02533583
• Other study ID #: guangdongwchhi1
• Status: Active, not recruiting
• Phase: N/A
• First received: August 4, 2015
• Last updated: August 11, 2016
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Guangdong Women and Children's Hospital and Health Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15000
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Device:
• pulse oximetry (PHILIPS intelliven MP5)
all newborn monitor pulse oximetry in left hand

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Women and Children's Hospital and Health Institute

References & Publications (3)

Bahadue FL, Soll R. Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev. 2012 Nov 14;11:CD001456. doi: 10.1002/14651858.CD001456.pub2. Review. — View Citation

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. — View Citation

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. Erratum in: Lancet. 2014 Aug 30;384(9945):746. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulse oximetry with clinical observation screen lung disease sensitivity	use wilson method to calculate the sensitivity	7 days	Yes
Secondary	pulse oximetry with clinical observation screen lung disease specificity	use wilson method to calculate the specificity	7 days	Yes
Secondary	pulse oximetry with clinical observation screen lung disease positive and negative value	use logistic regression model wo calculate the accuracy of the method	7 days	Yes