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Pulse oximetry screening of neonates for congenital heart disease
Abstract and Figures
We tried to discuss the impact of early diagnosis on outcome of critical congenital heart diseases (CCHDs), current options, and their limitations in timely diagnosis, utility of pulse oximetry screening (POS), current recommendations for screening and challenges in resource constrained countries and to suggest further avenues to cover existing gaps. Evidence acquisition process was performed on the PubMed database and Google scholar for every available article in peer reviewed journals. Prevalence of congenital heart disease (CHD) at birth is estimated to be 8/1,000 live births. About 25% of CHDs are life threatening CCHDs. The current guidelines for POS recommend that all neonates in well newborn nurseries should preferably be screened after 24 h of life. A screen is taken to be positive, “out of range” or a fail if oxygen saturation is (i)
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Introduction: Many studies have been done for screening of congenital heart disease (CHD) in the neonatal period utilizing pulse oximetry as a screening tool along with routine clinical assessment, but none of them from our province. Objective: The objective of the study was to find out the diagnostic accuracy of pulse oximeter at three different sites as a screening tool to diagnose CHD among neonates. Methods: A diagnostic study was conducted in neonatal intensive care unit of a tertiary care hospital of Odisha from October 2016 to September 2018 after approval from the Institutional Ethics Committee. Three hundred and seventy-four neonates (both inborn and outborn) with gestational age >34 weeks were included in the study. Oxygen saturation (SpO2) in the right hand (RH), right foot (RF), and left foot (LF) was estimated by pulse oximeter among all participants after 10 min of postnatal life. All the study subjects were evaluated by two-dimensional (2D) echocardiography for the detection of CHDs. All the diagnostic accuracy tests (sensitivity [Sn], specificity [Sp], positive predictive value, negative predictive value, and diagnostic odds ratio) were calculated taking 2D echocardiography as the gold standard with software, and for all statistical purpose, p<0.05 was considered statistically significant. Results: Cutoff value of the RH SpO2 was 90.0% with Sn of 68.80% and Sp of 98.20%; area under curve (AUC) 0.851 (0.766 and 0.914), p<0.001, for the RF, SpO2 was 90.0% with Sn 78.0% and Sp 92.1%; AUC 0.865 (0.782 and 0.925), p<0.001, and for LF, it was 87% with Sn 77.1% and Sp 94.0%; AUC 0.864 (0.781 and 0.924), p<0.001. Conclusion: Along with the clinical skills, pulse oximetry can be used as an early screening tool for the detection of CHD in the neonatal period and of three different sites, RF found to be better.
Background: Infants born with congenital heart disease (CHD) typically present different clinical manifestations which make this condition hard to diagnose. Considering serious complications arising from misdiagnosis, inventing new methods and/or improving traditional diagnostic approaches has always been a research objective. Methods: In this cross-sectional analysis, which took place in Children's Medical Center in Tehran, 150 infants admitted to an intensive care unit were evaluated based on echocardiographic findings from 2015 to 2017. Echocardiography was done due to abnormalities in physical examination and/or oxygen saturation level. Results: The sensitivity of clinical study value was 82% and the negative predictive value was 20%. The sensitivity of arterial oxygen saturation immediately after admission to the neonatal intensive care was 92%, the specificity was 34%, positive predictive value was 56% and negative predictive value was 25%. Conclusion: In terms of high sensitivity, clinical symptom including tachypnea, cyanosis, arrhythmias, respiratory distress, cardiac murmur, or arterial oxygen saturation level in newborns may be useful for screening CHD. Among the clinical manifestations, cyanosis and respiratory distress are more valuable.
Background
Life-threatening congenital heart defects (CHD) often go undetected. This prospective study assessed the accuracy of pulse oximetry as a screening test for CHD.
Methods
Pulse oximetry was performed in asymptomatic newborns >34 weeks gestation, prior to discharge from six maternity units. Those not achieving predetermined oxygen saturation thresholds underwent echocardiography. All other infants were followed up to age 12 months through interrogation of registries and clinical follow-up. The main outcome measure was detection of major CHD – subdivided into critical (death or intervention before 28 days), and serious (death or intervention between 1 and 12 months of age).
Findings
20 055 babies were screened and 53 had major CHD (24 critical, 29 serious). Pulse oximetry had a sensitivity of 75.0% (95%CI 53.3% to 90.2%) for critical cases and 49.1% (95%CI 35.1% to 63.2%) for all major CHD. In 35 cases CHD was already suspected following antenatal US, when these were excluded, pulse oximetry had a sensitivity of 58.3% (95%CI 27.7% to 84.8%) for critical cases and 28.6% (95%CI 14.6% to 46.3%) for all major CHD. False positive results occurred in 0.8% of babies (specificity: 99.2%, 95%CI 99.0% to 99.3%). However of the 169 false positives, there were six cases of significant (not major) CHD and 40 cases of illness requiring medical intervention.
Interpretation
Pulse oximetry is a safe, feasible test which adds value to existing screening. It identifies cases of critical CHD which go undetected with antenatal ultrasound screening. The early detection of other pathologies is an additional advantage.
Aim:
Limited data have been available regarding critical congenital heart disease (CHD) screening in neonatal intensive care unit (NICUs). This study evaluated the feasibility of screening for CHD by adding pulse oximetry (POX) to clinical evaluation in a NICU in Shanghai, China.
Methods:
We screened 4,128 eligible consecutive NICU admissions using POX plus clinical evaluation. Infants with positive screening results were then evaluated with echocardiography. Those with negative screening results were put under observation and they also underwent echocardiography if their oxygen saturation fell below 95% on room air during hospitalisation.
Results:
This enhanced procedure detected 19 critical CHD cases and seven of these diagnoses would have been delayed if POX had not been incorporated into the screening strategy. This means that the addition of POX increased the detection rate of critical CHD from 63.2% to 100%. The false-positive rate of critical CHD screening by using POX plus clinical evaluation was higher in NICU patients with high morbidity rates.
Conclusion:
When pulse oximetry screening was added to clinical evaluation it increased the number of critical CHD cases that were detected in our NICU. This method could provide a useful screening protocol for critical CHD cases. This article is protected by copyright. All rights reserved.
Congenital heart disease (CHD) is one of the most common birth defects, with an incidence of nine out of every 1,000 live births. The mortality of infants with CHD has decreased over the past 3 decades, but significant morbidity and mortality continue to occur if not diagnosed shortly after birth. Pulse oximetry was recommended as a screening tool to detect critical CHD in 2011 by the American Academy of Pediatrics and the American Heart Association. Pulse oximetry is a tool to measure oxygen saturation, and based on the presence of hypoxemia, many cardiac lesions are detected. Due to its ease of application to the patient, providing results in a timely manner and without the need for calibrating the sensor probe, pulse oximetry offers many advantages as a screening tool. However, pulse oximetry has also important limitations of which physicians should be aware to be able to assess the significance of the pulse oximetry measurement for a given patient. This review aims to highlight the benefits and shortcomings of pulse oximetry within the context of screening for critical CHD and suggests future avenues to cover existing gaps in current practices.
Objective:
To evaluate pulse oximetry for detection of congenital cyanotic heart disease in sick neonates using echocardiography as gold standard.
Methods:
Pulse oximetry readings were taken at admission from 950 neonates from right upper limb and either foot with infant breathing room air. Pulse oximetry was considered abnormal if oxygen saturation at room air measured <90% or difference between right hand and foot was more than 3%. Persistent abnormality was considered positive result. Echocardiography was performed on all neonates with positive pulse oximetry (study group) and on one subsequent neonate with negative screen for each neonate with positive screen (controls).
Results:
Pulse oximetry was positive in 210 neonates. It detected 20 out of 21 (95.2%) true positives. The sensitivity, specificity, positive predictive value, negative predictive value and odds ratio (95% CI) of pulse oximetry was 95.2%, 52.4%, 9.5, 99.5 and 22 (5.3, 91.4), respectively.
Conclusion:
Pulse oximetry screening is useful in detecting cyanotic heart diseases in sick newborns.
Neurodevelopmental disability is the most common complication for survivors of surgery for congenital heart disease (CHD).
We analyzed individual participant data from studies of children evaluated with the Bayley Scales of Infant Development, second edition, after cardiac surgery between 1996 and 2009. The primary outcome was Psychomotor Development Index (PDI), and the secondary outcome was Mental Development Index (MDI).
Among 1770 subjects from 22 institutions, assessed at age 14.5 ± 3.7 months, PDIs and MDIs (77.6 ± 18.8 and 88.2 ± 16.7, respectively) were lower than normative means (each P < .001). Later calendar year of birth was associated with an increased proportion of high-risk infants (complexity of CHD and prevalence of genetic/extracardiac anomalies). After adjustment for center and type of CHD, later year of birth was not significantly associated with better PDI or MDI. Risk factors for lower PDI were lower birth weight, white race, and presence of a genetic/extracardiac anomaly (all P ≤ .01). After adjustment for these factors, PDIs improved over time (0.39 points/year, 95% confidence interval 0.01 to 0.78; P = .045). Risk factors for lower MDI were lower birth weight, male gender, less maternal education, and presence of a genetic/extracardiac anomaly (all P < .001). After adjustment for these factors, MDIs improved over time (0.38 points/year, 95% confidence interval 0.05 to 0.71; P = .02).
Early neurodevelopmental outcomes for survivors of cardiac surgery in infancy have improved modestly over time, but only after adjustment for innate patient risk factors. As more high-risk CHD infants undergo cardiac surgery and survive, a growing population will require significant societal resources.
Copyright © 2015 by the American Academy of Pediatrics.
Objective:
Critical congenital heart disease (CCHD) screening is effective in asymptomatic late preterm and term newborn infants with a low false-positive rate (0.035%). (1) To compare 2817 neonatal intensive care unit (NICU) discharges before and after implementation of CCHD screening; and (2) to evaluate CCHD screening at <35 weeks gestation.
Study design:
Collection of results of CCHD screening including pre- and postductal pulse oximetry oxygen saturation (SpO2) values.
Result:
During the pre-CCHD screen period, 1247 infants were discharged from the NICU and one case of CCHD was missed. After 1 March 2012, 1508 CCHD screens were performed among 1570 discharges and no CCHDs were missed. The pre- and postductal SpO2 values were 98.8 ± 1.4% and 99 ± 1.3%, respectively, in preterm and 98.9 ± 1.3% and 98.9 ± 1.4%, respectively, in term infants. Ten infants had false-positive screens (10/1508 = 0.66%).
Conclusion:
Performing universal screening in the NICU is feasible but is associated with a higher false-positive rate compared with asymptomatic newborn infants.
Objective
To measure neurodevelopment at 3 years of age in children with single right-ventricle anomalies and to assess its relationship to Norwood shunt type, neurodevelopment at 14 months of age, and patient and medical factors.
Study design
All subjects in the Single Ventricle Reconstruction Trial who were alive without cardiac transplant were eligible for inclusion. The Ages and Stages Questionnaire (ASQ, n = 203) and other measures of behavior and quality of life were completed at age 3 years. Medical history, including measures of growth, feeding, and complications, was assessed through annual review of the records and phone interviews. The Bayley Scales of Infant Development, Second Edition (BSID-II) scores from age 14 months were also evaluated as predictors.
Results
Scores on each ASQ domain were significantly lower than normal (P < .001). ASQ domain scores at 3 years of age varied nonlinearly with 14-month BSID-II. More complications, abnormal growth, and evidence of feeding, vision, or hearing problems were independently associated with lower ASQ scores, although models explained <30% of variation. Type of shunt was not associated with any ASQ domain score or with behavior or quality-of-life measures.
Conclusion
Children with single right-ventricle anomalies have impaired neurodevelopment at 3 years of age. Lower ASQ scores are associated with medical morbidity, and lower BSID-II scores but not with shunt type. Because only a modest percentage of variation in 3-year neurodevelopmental outcome could be predicted from early measures, however, all children with single right-ventricle anomalies should be followed longitudinally to improve recognition of delays.
Critical congenital heart disease (CCHD) was recently added to the U.S. Recommended Uniform Screening Panel for newborns. This evaluation aimed to estimate screening time and hospital cost per newborn screened for CCHD using pulse oximetry as part of a public health economic assessment of CCHD screening.
A cost survey and time and motion study were conducted in well-newborn and special/intensive care nurseries in a random sample of seven birthing hospitals in New Jersey, where the state legislature mandated CCHD screening in 2011. The sample was stratified by hospital facility level, hospital birth census, and geographic location. At the time of the evaluation, all hospitals had conducted CCHD screening for at least four months.
Mean screening time per newborn was 9.1 (standard deviation = 3.4) minutes. Hospitals' total mean estimated cost per newborn screened was $14.19 (in 2011 U.S. dollars), consisting of $7.36 in labor costs and $6.83 in equipment and supply costs.
This federal agency-state health department collaborative assessment is the first state-level analysis of time and hospital costs for CCHD screening using pulse oximetry conducted in the U.S. Hospitals' cost per newborn screened for CCHD with pulse oximetry is comparable with cost estimates of existing newborn screening tests. Hospitals' equipment costs varied substantially based on the pulse oximetry technology employed, with lower costs among hospitals that used reusable screening sensors. In combination with estimates of screening accuracy, effectiveness, and avoided costs, information from this evaluation suggests that CCHD screening is cost-effective.
BACKGROUND
Congenital heart diseases are the most common congenital malformations and account for 6-10% of all infant deaths.
Congenital heart defects affect 8 to 10 out of every 1000 live births. Pulse oximetry in newborn screening can detect mild
hypoxemia that may not be recognised by clinical examination. Thus, pulse oximetry can help to identify babies that may be
affected with critical congenital heart disease before they leave the newborn nursery. There are many studies carried out on
pulse oximetry with different sensitivity and specificity for detection of congenital heart disease. The objectives of the present
study were to screen all newborns admitted in NICU to rule out congenital heart disease before discharge and to find out the
utility of pulse oximetry to detect congenital heart disease.
METHODS
This prospective study was conducted in Neonatal Intensive Care unit, Gauhati Medical College and Hospital in 1720 neonates
over a period of 12 months (February 2015 to January 2016). Both pulse oximetry and clinical examination were done.
Persistent pulse oximetry (SPO2) reading below 95% or more than 3% difference between right hand and one foot, it was
considered as positive pulse oximetry. Newborns with positive pulse oximetry and abnormal clinical examination findings were
subjected to echocardiography.
RESULTS
Positive pulse oximetry cases were 47(2.73%), out of which 39 cases had only positive pulse oximetry (with negative clinical
examination). Positive clinical examination cases were 58(3.37%), out of which 50 cases had only positive clinical examination
findings (with negative pulse oximetry). Eight (8) cases had both positive pulse oximetry and positive clinical examination.
Total congenital heart disease cases detected in our study was 34(1.98%) out of 1720. VSD was the most common CHD
followed by PDA, TOF, TGA in this study. The sensitivity, specificity, positive predictive value and negative predictive value of
pulse oximetry were 41.18%, 98.04%, 29.79%, 98.80% respectively.
CONCLUSION
Pulse oximetry is a useful tool to detect congenital heart disease. Its accuracy in detecting congenital heart disease increases
if combined with positive clinical examination.
Objective:
Pulse oximetry screening (POS) is an effective tool to detect critical congenital heart disease (CCHD) in asymptomatic term infants, but its value in the neonatal intensive care unit (NICU) requires further clarification.
Study design:
A retrospective review of 1005 babies without previously diagnosed CCHD admitted to a level III NICU was performed to assess the risk for missed CCHD and performance of POS.
Result:
Of the 1005 NICU patients, 812 had documented POS and none failed POS. In 812 patients, 547 had delayed POS because of the use of supplemental oxygen. In 259/812 patients, POS was delayed until the baby was >2 weeks old. CCHD was excluded by echocardiography, irrespective of POS, in 287/1005 patients.
Conclusion:
POS can be performed in the NICU with minimal adverse effects. However, in many NICU patients CCHD is confirmed or excluded before POS, and POS will frequently be performed after CCHD would have been expected to become symptomatic.Journal of Perinatology advance online publication, 5 November 2015; doi:10.1038/jp.2015.150.