Pulse oximetry with clinical assessment to screen for congenital heart disaese in neonates in...

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Pulse oximetry with clinical assessment to screen for

congenital heart disease in neonates in China:a prospective study

Qu-ming Zhao*, Xiao-jing Ma*, Xiao-ling Ge, Fang Liu, Wei-li Yan, Lin Wu, Ming Ye, Xue-cun Liang, Jing Zhang, Yan Gao, Bing Jia,

Guo-ying Huang, and the Neonatal Congenital Heart Disease screening group

SummaryBackground Several pioneering studies have provided evidence for the introduction of universal pulse oximetryscreening for critical congenital heart disease. However, whether the benefits of screening reported in studies fromhigh-income countries would translate with similar success to low-income countries is unknown. We assessed thefeasibility and reliability of pulse oximetry plus clinical assessment for detection of major congenital heart disease,especially critical congenital heart disease, in China.

Methods We did a pilot study at three hospitals in Shanghai to assess the accuracy of pulse oximetry plus clinicalassessment for detection of congenital heart disease. We made a data collection plan before recruitment. We thenundertook a large, prospective, and multicentre screening study in which we screened all consecutive newborn babies(aged 672 h) born at 18 hospitals in China between Aug 1, 2011, and Nov 30, 2012. Newborn babies with positive screenresults (either an abnormal pulse oximetry or abnormal clinical assessment) were referred for echocardiographywithin 24 h of screening. We identified false-negative results by clinical follow-up and parents feedback. We calculatedsensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios for pulseoximetry alone, and in combination with clinical assessment, for detection of major and critical congenital heart disease.

FindingsIn the pilot study, 6785 consecutive newborn babies were screened; 46 of 49 (94%) cases of asymptomaticmajor congenital heart disease and eight of eight (100%) cases of asymptomatic critical disease were detected by pulseoximetry and clinical assessment. In the prospective multicentre study, we screened 122 738 consecutive newborn

babies (120 707 asymptomatic and 2031 symptomatic), and detected congenital heart disease in 1071 (157 critical and330 major). In asymptomatic newborn babies, the sensitivity of pulse oximetry plus clinical assessment was 932%(95% CI 879962) for critical congenital heart disease and 902% (864930) for major disease. The addition ofpulse oximetry to clinical assessment improved sensitivity for detection of critical congenital heart disease from774% (95% CI 700834) to 932% (879962). The false-positive rate for detection of critical disease was 27%(3298 of 120 392) for clinical assessment alone and 03% (394 of 120 561) for pulse oximetry alone.

InterpretationPulse oximetry plus clinical assessment is feasible and reliable for the detection of major congenitalheart disease in newborn babies in China. This simple and accurate combined method should be used in maternityhospitals to screen for congenital heart disease.

FundingKey Clinical Research Project sponsored by Ministry of Health, Shanghai Public Health Three-Year ActionPlan sponsored by Shanghai Municipal Government, and National Basic Research Project of China.

IntroductionCongenital heart defects are a leading cause of infantdeath in high-income countries, and affect eight of1000 livebirths.1 About one to two per 1000 newbornbabies have critical congenital heart disease, which isdefined as disease that causes death or needs invasiveintervention in the neonatal period, and neonates withthis disease benefit most from early detection.2Duringthe past few years, several pioneering studies haveprovided compelling evidence for the addition of pulseoximetry to fetal ultrasound screening and routineclinical assessment as a complementary method fordetection of critical congenital heart disease.38In view ofstrong supporting evidence, this method was consideredin several high-income countries to detect critical

disease.912However, many children born with simple butserious congenital heart disease (such as large ventricularseptal defects) in low-income countries cannot berecognised early enough to avoid irreversible pulmonaryvascular disease.13,14Therefore, all major congenital heartdiseases (those causing death or requiring invasiveintervention during infancy) should be regarded as maintargets of neonatal screening in low-income countries.

Although favourable outcomes of studies of pulseoximetry in high-income countries might not predictsimilar success in low-income countries, we believed thatlower prenatal and postnatal detection rates in low-income countries would increase the benefit of screening.However, pulse oximetry should not preclude routineclinical assessment, which can sometimes detect a

Lancet2014; 384: 74754

Published Online

April 23, 2014

http://dx.doi.org/10.1016/

S0140-6736(14)60198-7

This online publication has

been corrected. The corrected

version first appeared at

thelancet.com on Aug 29, 2014

SeeCommentpage 725

*Contributed equally

Contributed equally

For members see end of report

Paediatric Heart Centre,

Childrens Hospital of Fudan

University, Shanghai, China

(Q-m Zhao MD,X-j Ma MD,

X-l Ge MD, Prof F Liu MD,

Prof W-l Yan MD, L Wu MD,

M Ye MD, X-c Liang MD,

J Zhang MD, Y Gao MD,

Prof B Jia MD,Prof G-y Huang MD);and

Shanghai Key Laboratory of

Birth Defects, Shanghai, China

(X-j Ma, X-l Ge, Prof W-l Yan,

Prof G-y Huang)

Correspondence to:

Dr Guo-ying Huang, Pediatric

Heart Center, Childrens Hospital

of Fudan University, Shanghai

201102, China

[email protected]

Or

Dr Bing Jia, Pediatric Heart

Center, Childrens Hospital of

Fudan University, Shanghai

201102, [email protected]
http://crossmark.crossref.org/dialog/?doi=10.1016/S0140-6736(14)60198-7&domain=pdf


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serious congenital heart disease before the development

of hypoxia. China is the largest developing country in theworld, with an annual birth rate of roughly 16 million.15Nearly 56% of newborn babies have a birth defect, 27%of which is congenital heart disease.15Because of a paucityof large-scale screening for neonatal congenital heartdisease in low-income countries, whether pulse oximetryplus clinical assessment could lead to major progress intimely detection of serious disease in these countriesmight be diffi cult to establish. We aimed to assess thefeasibility and reliability of pulse oximetry plus clinicalassessment for detection of major congenital heartdisease, especially critical congenital heart disease, innewborn babies in China.

MethodsStudy design and participantsWe did a pilot study in three hospitals in Shanghai(Songjiang Maternity Hospital, Minhang MaternityHospital, and Songjiang District Central Hospital)between Feb 1, 2011, and July 31, 2011, to assess thepracticability and accuracy of pulse oximetry plus clinicalassessment screening for the detection of congenitalheart disease in newborn babies. The three hospitals wereselected as being representative of most birthing facilitiesin China. Findings of the pilot study showed that pulseoximetry used in conjunction with clinical assessmentcould be successfully implemented in common hospitalsettings with few barriers, and resulted in a high detectionrate of major and critical congenital heart disease.

To verify the pilot study, we did a multicentreprospective screening study between Aug 31, 2011, andNov 30, 2012, in 18 hospitals in China. Of the18 hospitals, 12 were located in the east (two in Shanghai,three in Jiangsu Province, three in Zhejiang Province,two in Shandong Province, and two in Fujian Province),six in the west (one in Shanxi Province, one in Gansu

Province, two in Guizhou Province, one in Sichuan

Province, and one in Guangxi Province). 16 hospitals(89%) had echocardiography on site and the two withoutechocardiography stated that referral for cardiologyconsultation in a nearby facility could be immediatelyavailable. All consecutive newborn babies were eligible(irrespective of gestational age or neonatal intensivecare unit status), but newborn babies with prenatallydiagnosed congenital heart disease were excludedbefore screening with a postnatal echocardiogram.

This study was approved by ethics committee ofChildrens Hospital of Fudan University. Oral informedconsent was obtained from the participating babiesparents.

ProceduresFor the screening study, in the asymptomatic neonatecohort (without tachypnoea or cyanosis), a trainedclinician did universal pulse oximetry screening with anew generation RAD-5v pulse oximeter (Masimo, Irvine,CA, USA) with a multisite reusable sensor (LNOP YI,Masimo). In the neonatal intensive care unit setting,disposable sensors (LNOP Inf-L, Masimo) were used.Testing was done in babies aged between 6 h and 72 h.We used measurement criteria proposed by the USSecretary of Health and Human Services to implementscreening.9The clinician repeated pulse oximetry testing4 h later if the first pulse oximeter oxygen saturation(SpO

2

) measurement was between 90% and 95%.Screening was deemed positive if an SpO2of less than95% was obtained both on the right hand and on eitherfoot on two measures, separated by 4 h; a differencebetween the two extremities was more than 3% on twomeasures, separated by 4 h; or any measure was lessthan 90%.

The same clinician did clinical assessment just beforepulse oximetry measurement, to ensure that the clinicalassessment result would not be affected by knowledge ofpulse oximetry test. If the SpO2was very low (


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underwent echocardiography within 1 h of the index test

by a doctor who was masked to the results of the indextest. In the multicentre screening study, the referencestandard was echocardiography, clinical follow-up, andparents feedback. Newborn babies who screened positivefor congenital heart disease were referred forechocardiography within 24 h of screening. Late-presenting cases of congenital heart disease wereidentified through re-assessment by clinical examinationat 6 weeks of age at the hospital where the newborn babyhad been born; if the baby had congenital heart diseaseafter 6 weeks of age, parents were recommended tocontact the hospital. The Childrens Hospital of FudanUniversity provided help with further confirmation ofdiagnosis for all affected babies from the participating

hospitals. All cases of congenital heart disease werefollowed up by telephone review at atleast 1 year of age.

On the basis of the severity classification of congenital

heart disease recommended by Ewer and colleagues,

3

we divided cases of the disease into four groups: critical(defects causing death or needing intervention before28 days of age), serious (defects needing interventionbefore 1 year of age), significant (defects persistinglonger than 6 months of age, but not classified ascritical or serious), and non-significant (defects notphysically appreciable and not persisting after 6 monthsof age). We classified critical and serious cases ofcongenital heart disease as major congenital heartdisease; the other two groups were classified as minorcongenital heart disease. Critical congenital heartdisease was the main screening target, and seriouscongenital heart disease was the secondary. We made a

data collection plan before we started to recruit studyparticipants at all sites.

130282 deliveries

120707 asymptomatic newborns 2031 symptomatic newborns

120

707 clinical assessment plus pulse oximetry 2031 clinical assessment plus pulse oximetry

120707 pulse oximetry

120191 negative results

Clinical follow-up andparents feedback

516 positive results

120707 clinical assessment

Echocardiography

3571 incomplete screening data1450 lack of consent2496 transfer to superior hospital 27 prenatally diagnosed major CHD

212 CHD 122 critical 63 serious 22 significant 5 non-significant304 no CHD

839 CHD 113 critical 143 serious 560 significant 23 non-significant2546 no CHD

874 CHD 136 critical

148 serious 566 significant 24 non-significant2708 no CHD

171 CHD 10 critical

21 serious 37 significant 103 non-signifi- cant116954 no CHD

117125 negative results 3582 posit ive results

24 CHD 11 critical

3 serious 6 significant 4 non-significant 111 no CHD

2 CHD 1 serious

1 significant 1894 no CHD

1896 negative results 135 positive results

117322 negative results 3385 posit ive results

Figure:Study profileCHD=congenital heart disease.


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Statistical analysis

We calculated the sample size for the pilot study with thedetection rate of routine clinical assessment (50%) usedby Wren and colleagues.16On the basis of a prevalence ofcongenital heart disease of eight per 1000 livebirths (andassuming a 50% sensitivity and 90% specificity of routineclinical assessment), and with a sample size of 6700(including 54 cases of congenital heart disease), the studyhad 99% power to prove the sensitivity was at least 80%with a two-sided test with type I error of 5%. The samplesize needed to detect a 5% increase in specificity from90% was 552 on the basis of a two-sided test with type Ierror of 5% (99% power).

For the asymptomatic cohort, we calculated sensitivity,specificity, positive and negative predictive value, and

positive and negative likelihood ratios for pulse oximetryalone and in combination with clinical assessment. 95%CI of sensitivity and specificity was computed by theWilson method. We used McNemars test to comparedifferences in sensitivity and specificity between pulseoximetry alone and in combination with clinicalassessment. We used a logistic regression model tocalculate the accuracy of pulse oximetry and clinicalassessment according to the timing of screening, withtime from birth to the first stage of pulse oximetry as acontinuous variable.

Role of the funding sourceThe Key Clinical Research Project sponsored by Ministryof Health, Shanghai Public Health Three-Year ActionPlan sponsored by Shanghai Municipal Government,and National Basic Research Project of China monitoredstudy progress but had no role in study design, datacollection, data analysis, data interpretation, or writing ofthe report. The corresponding authors had full access to

all the data in the study and had final responsibility for

the decision to submit for publication.

ResultsDuring the pilot study, 6785 livebirths were recorded inthe three hospitals. Of these, 35 newborn babiespresented with tachypnoea or cyanosis before screening;the symptoms were caused by a lung problem, and nocongenital heart disease was detected. The remaining6750 newborn babies were asymptomatic at the time ofscreening. The median age of screening was 43 h(range297). Pulse oximetry test was done for a mean of16 min (range 0840). Pulse oximetry plus clinicalassessment detected 46 of 49 cases (94% sensitivity) ofasymptomatic major congenital heart disease and eight

of eight cases (100% sensitivity) of critical congenitalheart disease. The corresponding specificity was 93%(6226 of 6701) and 92% (6228 of 6742). Pulse oximetryplus cardiac murmur had the same sensitivity(46 of 49 [94%]) but a higher specificity for detection ofmajor congenital heart disease than pulse oximetry plusclinical assessment (6267 of 6701 [94%] vs6226 of 6701 [93%]). However, if the pulse oximetry testhad not been introduced, one critical congenital heartdisease (single ventricle with pulmonary atresia) and onemajor congenital heart disease (double outlet rightventricle) would have been missed. The false-positiverate of the pulse oximetry test was 03% (16 of 6701) formajor congenital heart disease and 03% (17 of 6742) forcritical congenital heart disease.

Findings of the pilot study showed that pulse oximetryused in conjunction with clinical assessment could besuccessfully implemented in common hospital settingswith few barriers because of short screening time, littleadditional workload, and easy performance, and resultedin a high detection rate of major and critical congenitalheart disease. Data suggested that a prospective multicentrestudy in a larger population was feasible in China.

In the prospective study, of 130 282 deliveries, wescreened 122 738 newborn babies (94%) in China (figure),including 120 707 asymptomatic newborn babies and2031 symptomatic newborn babies (table 1). 27 newborn

babies with major congenital heart disease (22 criticaland five serious) were prenatally diagnosed and verifiedby immediate postnatal echocardiography; thesenewborn babies were excluded from the study analysis.

In the asymptomatic neonate cohort, the median age atpulse oximetry plus clinical assessment screening was43 h (range 672). Table 1 shows the percentage ofpositive results based on different methods. 874 patientswith congenital heart disease (including 136 critical and148 serious) were identified before discharge. Anadditional 171 patients with congenital heart disease(including ten critical and 21 serious) were diagnosedlater by clinical follow-up and parents feedback (figure).

Pulse oximetry alone as a screening method detected122 of 146 (84%) cases of asymptomatic critical congenital

Asymptomatic newborn

babies (n=120 707)

Symptomatic newborn

babies (n=2031)

Gestational age (weeks)

40 534 (


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heart disease, but only 185 of 315 (59%) cases ofasymptomatic major congenital heart disease (table 2).Table 3 shows sensitivities of pulse oximetry forindividual critical congenital heart disease. Comparedwith clinical assessment, pulse oximetry had higherdetection rate of total anomalous pulmonary venousconnection, transposition of the great arteries, pulmonaryatresia, and double outlet right ventricle, whereas clinicalassessment detected more critical left heart obstructivedefects including hypoplastic left heart syndrome, criticalcoarctation of the aorta, interrupted aortic arch, andcritical aortic stenosis (11 of 22 [50%] vsnine of 22 [41%]).

The overall false-positive rate for detection of criticalcongenital heart disease was 03% (394 of 120 561) forpulse oximetry alone (table 1). However, 180 (46%) falsepositives by pulse oximetry needed medical interventionor further monitoring (90 with other congenital heartdisease, 41 persistent pulmonary hypertension of the

newborn, 23 lung problem, 16 preterm birth, and teninfection). Thus, the true false-positive rate for pulseoximetry alone was 02% (214of 120 561). We recorded asignificant decrease in the false-positive rate for pulseoximetry with age of newborn baby at screening (oddsratio [OR] 067, 95% CI 057078, p


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discharge would have been increased to 94% (156 of 166).In the ten missed cases of critical congenital heart diseasebefore discharge, left-heart obstructive defects constitutedsix cases (with five readmitted in the collapsed status) andcyanotic heart defects four (all identified by physicianduring clinical follow-up at 6 weeks of age).

Pulse oximetry plus cardiac murmur had the sameaccuracy as did pulse oximetry plus clinical assessment(four aspects) in the detection of major congenital heartdisease (90% sensitivity) and critical congenital heartdisease (93% sensitivity), whereas the false-positive ratewas significantly lower (2876 of 120 392 [24%]) vs 3298 of120 392 [27%]) for major congenital heart disease(p


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disease will need an echocardiogram. But the results of

clinical assessment are probably affected by thephysicians clinical experience, especially in low-incomecountries where physician training varies from universitygraduate training in provincial to 3 months aftersecondary school in villages. To reduce interobservervariability in clinical assessment, we standardised thedefinition of a presumptively positive clinical assessmentresult. Findings of our study showed that pulse oximetryplus cardiac murmur and pulse oximetry plus all fouraspects of clinical assessment had the same sensitivity indetection of asymptomatic major congenital heartdisease, making screening quick and simple.

Several well designed studies of pulse oximetry screeninghave been published,38 but the absence of agreed

definitions makes direct comparisons between themdiffi cult. In a meta-analysis19of 13 studies that focused onpulse oximetry alone as a screening method for detectionof asymptomatic critical congenital heart disease,Thangaratinam and colleagues reported that overallestimate of sensitivity was 765% (95% CI 677835).Compared with other studies,35,7even if the same inclusioncriteria of critical congenital heart disease were used, ourdata still suggested a higher sensitivity of pulse oximetrythan in the meta-analysis (>80%; appendix). The highersensitivity in our study was probably related to the lowerproportion of left-heart obstructive defects in newbornbabies with critical congenital heart disease, becausedetection of aortic obstruction with pulse oximetry aloneremains diffi cult (appendix).20,21 Furthermore, theprevalence of all left-heart obstructive defects in our study(040 per 1000 livebirths) was also lower than in previouslyreported estimates from studies done in high-incomecountries (eg, 081 per 1000 livebirths in Germany,22082 per 1000 in Atlanta, USA23), whereas we recordedmore right-heart obstructive defects (106 per 1000 livebirthsvs076 per 1000 in Germany,22059 per 1000 in Atlanta23).

In 2011, the Advisory Committee on Heritable Disordersin Newborns and Children of the US Health and HumanServices Secretary investigated seven specific lesions asprimary targets for screening on the basis of advice froma technical expert panel:9hypoplastic left heart syndrome,

pulmonary atresia, tetralogy of Fallot, total anomalouspulmonary venous connection, transposition of greatarteries, tricuspid atresia, and truncus arteriosus.However, the panel also recommended that, Comparingthe accuracy of pulse oximetry monitoring for the sevendefects to that of other studies was challenging because ofdifferences in the lesions that were targeted for detectionby the screening.9In our study, pulse oximetry detected138 of 164 cases with the seven asymptomatic criticalcongenital heart diseases (sensitivity 841%), whichincluded hypoplastic left heart syndrome (four of seven),pulmonary atresia (34 of 34), tetralogy of Fallot (42 of 55),total anomalous pulmonary venous connection (15 of 20),transposition of great arteries (32 of 33), tricuspid atresia(six of seven) and truncus arteriosus (five of eight).

With regard to the false-positive rate of pulse oximetry,our results were nearly identical with those in the recentmeta-analysis; false-positive rate was affected by timing ofthe test and was significantly lower when the screening wasdone after 24 h of birth than when it was done before 24 h(table 4). We also noted this trend for clinical assessment.However, sensitivity for both pulse oximetry and clinicalassessment did not differ significantly during the study.

In practice, diagnostic echocardiography would alsofollow an abnormal clinical assessment, which identifiedmost cases of asymptomatic congenital heart disease(839 of 1045 [80%] in our study; figure 1). We could notdisregard the information about less critical disease. Inview of this association, we presented all cases ofcongenital heart disease identified through our screeningprogramme, clinical follow-up, and parents feedback in

this study. The appendix shows the prevalence andseverity of individual congenital heart disease lesions.

In China, no congenital anomaly registry or autopsydata are available to verify the cause of infant death thatmight be related to congenital heart disease. Additionally,identification of the missed cases by study of all hospitaladmissions for congenital heart disease is diffi cult becauseof the great population mobility. Nonetheless, data fromthe pilot study suggested that all cases of critical congenitalheart disease and 94% of cases of major disease casescould have been detected by pulse oximetry plus clinicalassessment before discharge. Therefore, very few cases ofcritical or major congenital heart disease are likely to havebeen missed through screening, clinical examination at6 weeks of age, and parents feedback in the main study.

Panel :Research in context

Systematic review

We searched Medline (from Jan 1, 1951, to Dec 31, 2013), Embase (from Jan 1, 1974, to

Dec 31, 2013), and the Cochrane Library (from inception to Dec 31, 2013) for systematic

reviews and primary studies of screening for congenital heart disease in neonates.

Language restrictions were not applied. A combination of MeSH and text words was used

as congenital heart disease AND screen AND (neonate OR newborn) to generate a

subset of citations relevant to our research question. We identified three closely related

systematic reviews and 14 primary studies.

Interpretation

This study is the largest test accuracy study of congenital heart disease screening with

more than twice as many babies screened than in the previous largest study.7We showed

for the first time the performance of pulse oximetry and clinical assessment in a low-

income country. Because most physicians in less-privileged areas in China are less able toclinically diagnose congenital heart disease than are those in more privileged areas,

mainly because of little exposure to paediatric cardiology during their training period, we

predict that clinical assessment added to pulse oximetry screening would help to diagnose

cases of major congenital heart disease. The results of this study add to the strong

evidence that suggests potential benefits of congenital heart disease screening in early

neonatal stage.38,12,19,20The screening strategy with pulse oximetry plus abnormal cardiac

murmur proved to be an effective and convenient method for detection of asymptomatic

major and critical congenital heart disease, which provided a strong argument for

implementation of routine congenital heart disease screening in low-income countries.

See Onlinefor appendix


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References1 van der Linde D, Konings EE, Slager MA, et al. Birth prevalence of

congenital heart disease worldwide: a systematic review andmeta-analysis.J Am Coll Cardiol2011; 58:224147.

2 Chang RK, Gurvitz M, Rodriguez S. Missed diagnosis of criticalcongenital heart disease. Arch Pediatr Adolesc Med2008; 162:96974.

3 Ewer AK, Middleton LJ, Furmston AT, et al, and the PulseOx StudyGroup. Pulse oximetry screening for congenital heart defects innewborn infants (PulseOx): a test accuracy study. Lancet2011;378:78594.

4 Riede FT, Wrner C, Dhnert I, Mckel A, Kostelka M, Schneider P.Effectiveness of neonatal pulse oximetry screening for detection ofcritical congenital heart disease in daily clinical routineresultsfrom a prospective multicenter study. Eur J Pediatr2010; 169:97581.

5 de-Wahl Granelli A, Wennergren M, Sandberg K, et al. Impact ofpulse oximetry screening on the detection of duct dependentcongenital heart disease: a Swedish prospective screening study in39,821 newborns. BMJ2009; 338:a3037.

6 Sendelbach DM, Jackson GL, Lai SS, Fixler DE, Stehel EK,Engle WD. Pulse oximetry screening at 4 hours of age to detectcritical congenital heart defects. Pediatrics2008; 122:e81520.

7 Meberg A, Brgmann-Pieper S, Due R Jr, et al. First day of lifepulse oximetry screening to detect congenital heart defects.J Pediatr2008; 152:76165.

8 Arlettaz R, Bauschatz AS, Mnkhoff M, Essers B, Bauersfeld U. Thecontribution of pulse oximetry to the early detection of congenitalheart disease in newborns. Eur J Pediatr2006; 165:9498.

9 Kemper AR, Mahle WT, Martin GR, et al. Strategies forimplementing screening for critical congenital heart disease.Pediatrics2011; 128:e125967.

10 Kuelling B, Arlettaz Mieth R, Bauersfeld U, Balmer C. Pulseoximetry screening for congenital heart defects in Switzerland:most but not all maternity units screen their neonates.Swiss Med Wkly2009; 139:699704.

11 Singh A, Ewer AK. Pulse oximetry screening for critical congenitalheart defects: a UK national survey. Lancet2013; 381:535.

12 Turska Kmie A, Borszewska Kornacka MK, Ba W, Kawalec W,

Zuk M. Early screening for critical congenital heart defects inasymptomatic newborns in Mazovia province: experience of thePOLKARD pulse oximetry programme 2006-2008 in Poland.Kardiol Pol2012; 70:37076.

13 Ho TC, Ouyang H, Lu Y, Young AH, Chintala K, Detrano RC.Postprocedural outcomes of rural children undergoing correction ofcongenital heart lesions in Yunnan Province, China. Pediatr Cardiol2011; 32:81114.

14 Saxena A. Congenital cardiac surgery in the less privileged regionsof the world. Expert Rev Cardiovasc Ther2009; 7:162129.

15 Ministry of Health of the Peoples Republic of China. National birthdefects control and prevention report (2012). Sept, 2012. http://www.gov.cn/gzdt/att/att/site1/20120912/1c6f6506c7f811bacf9301.pdf(accessed Oct 25, 2013).

16 Wren C, Richmond S, Donaldson L. Presentation of congenitalheart disease in infancy: implications for routine examination.Arch Dis Child Fetal Neonatal Ed1999; 80:F4953.

17 Hoffman JI. It is time for routine neonatal screening by pulse

oximetry. Neonatology2011; 99:19.18 Wu KH, L XD, Liu YL. Recent progress of pediatric cardiac surgery

in China. Chin Med J (Engl)2006; 119:200512.

19 Thangaratinam S, Brown K, Zamora J, Khan KS, Ewer AK.Pulse oximetry screening for critical congenital heart defects inasymptomatic newborn babies: a systematic review andmeta-analysis. Lancet2012; 379:245964.

20 Ewer AK. Review of pulse oximetry screening for critical congenitalheart defects in newborn infants. Curr Opin Cardiol2013; 28:9296.

21 Ewer AK. How to develop a business case to establish a neonatalpulse oximetry programme for screening of congenital heartdefects. Early Hum Dev2012; 88:91519.

22 Lindinger A, Schwedler G, Hense HW. Prevalence of congenitalheart defects in newborns in Germany: Results of the firstregistration year of the PAN Study (July 2006 to June 2007).Klin Padiatr2010; 222:32126.

23 Reller MD, Strickland MJ, Riehle-Colarusso T, Mahle WT, Correa A.

Prevalence of congenital heart defects in metropolitan Atlanta,19982005.J Pediatr2008; 153:80713.

Findings of our study showed that the benefits of pulse

oximetry recorded in high-income countries could betranslated with great success to China. However, allnewborn babies with major congenital heart diseaseshould be targeted for screening in low-income countries.Pulse oximetry plus abnormal cardiac murmur proved tobe an accurate and quick method for detection ofasymptomatic major congenital heart disease and criticalcongenital heart disease. The results of this study providea strong argument for implementation of screening forcongenital heart disease as a basic routine in Chinesematernity hospitals.

Contributors

G-yH and BJ contributed to the study design and the establishment ofthe screening system. All authors discussed, critically revised, and

approved the final study protocol. G-yH, BJ, X-jM, Q-mZ, and X-lGorganised and conducted the project. Q-mZ, X-jM, X-lG, and W-lYundertook data management and data analysis. All authors discussedand approved the final strategy for analysis. Q-mZ and X-jM drafted thefirst version of the report. All authors discussed, revised, and approvedthe final version of the report for publication.

Neonatal Congenital Heart Disease screening group

Guo-ying Huang, Bing Jia, Qu-ming Zhao, Xiao-jing Ma, Xiao-ling Ge,Fang Liu, Wei-li Yan, Lin Wu, Ming Ye, Xue-cun Liang, Jing Zhang,Yan Gao, Wei-fen Luo, Wei-qiang Tan, Xiao-jing Hu, Xian-gang Yan(Childrens Hospital of Fudan University, Shanghai, China);Wen-hong Yang, Xia Han (Kunshan Maternity and Child Health CareHospital, Jiangsu, China); Li-ping Xiao, Jun Huang (Minhang Maternityand Child Health Care Hospital, Shanghai, China); Ai-hua Zhang (TaianMaternity and Child Health Care Hospital, Shandong, China);Le-yuan Zhang (Zaozhuang Maternity and Child Health Care Hospital,Shandong, China); Yan-an Zhou (Quanzhou Women and Childrens

hospital, Fujian, China); De-yi Zhuang (The First Affi liated Hospital ofXiamen University, Fujian, China); Jiang-jin Zhou (Ningbo Women andChildrens hospital, Zhejiang, China); Wei-dong Su (WenzhouChildrens Hospital, Zhejiang, China); Jin-xiu Wang (ChangzhouMaternity and Child Health Care Hospital, Jiangsu, China); Xin-nianPan (Guangxi Maternity and Child Health Care Hospital, Guangxi,China); Dong-hai Liu (Gansu Maternity and Child Health Care Hospital,Gansu, China); Liang-rong Han (Huaian Maternity and Child HealthCare Hospital, Jiangsu, China); Zhi-rong Fan (Songjiang district centralhospital, Shanghai, China); Ying Wang (Songjiang maternity and childhealth hospital, Shanghai, China); Ling Liu (Guiyang Maternity andChild Health Care Hospital, Guizhou, China); Juan Chen (Affi liatedHospital of Zunyi Medical College, Guizhou, China); Jing Yu (MianyangCentral Hospital, Sichuan, China); Xiang-ming Zhou (Jiaxing Maternityand Child Health Care Hospital, Zhejiang, China); Gui-fang Cai (JiadingMaternity and Child Health Care Hospital, Shanghai, China); andShi-ping Liu (Affi liated Hospital of Yanan University, Shaanxi, China) .

Declaration of interests

We declare that we have no competing interests.

Acknowledgments

Our study was funded by the Key Clinical Research Project Sponsored byMinistry of Health (BJ and G-yH, number 2010239), Shanghai PublicHealth Three-Year Action Plan Sponsored by Shanghai MunicipalGovernment (G-yH, number 201155), and National Basic ResearchProject of China (G-yH, number2010CB529504). We thank allprofessionals involved in the Neonatal Congenital Heart DiseaseScreening Project; Wyman W Lai (Morgan Stanley Childrens Hospitalof New York Presbyterian, NY, USA) and Yiu-fai Cheung (University ofHong Kong, Hong Kong, China) for their comments and review of thereport; Jian-feng Xu (Wake Forest School of Medicine, Winston-Salem,NC, USA) and Duo-lao Wang (University of London, London, UK) fortheir valuable comments on the revision of the report; andAnne de-Wahl Granelli from Queen Silvia Childrens Hospital

(Gothenburg, Sweden) for serving as our advisory board.

Pulse oximetry with clinical assessment to screen for congenital heart disaese in neonates in...

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Transcript of Pulse oximetry with clinical assessment to screen for congenital heart disaese in neonates in...