Clinical trial NCT02533583: Pulse Oximetry With Clinical Observation to Screen for Lung Disease in Neonates
Official title: Pulse Oximetry With Clinical Observation to Screen for Lung Disease in Neonates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Diseases
Keywords: pulse oximetry
clinical assessment
neonate
lung disease
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 15000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants will born in 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.

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.

Eligibility 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

Primary outcomes:
measure: pulse oximetry with clinical observation screen lung disease sensitivity
timeFrame: 7 days
Secondary outcomes:
measure: pulse oximetry with clinical observation screen lung disease specificity
timeFrame: 7 days
measure: pulse oximetry with clinical observation screen lung disease positive and negative value
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Guangdong Women and Children Hospital
name: jie yang, doctor
role: STUDY_CHAIR
References:
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.
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.
citation: 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.