Material & Methods
This hospital-based prospective study was conducted in the Neonatology Unit of Pediatric Department at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi Meghe, Wardha from August 2013 to February 2015. All newborns delivered in these hospital including preterm babies were included in the study. Neonates with a prenatal diagnosis of duct dependent circulation by fetal echocardiography and out-born babies were excluded. An informed consent was obtained from one of the parents (preferably by mother) before initial screening and the purpose of the screening was explained to them. The measurements of SpO2 were performed using a Massimo Single Extraction Technology (SET) handheld pulse oximeter with a neonatal reusable Nellcor SpO2 sensor OXI-A/N probe. SpO2 was measured within the first 4 hours of life by a trained social worker on all the limbs of the newborn. The pulseoximetry probe was held manually to the palm or wrist and to the sole, following a random order and measured the saturation (Figure 1).
Inclusion criteria: All newborns who admitted in postnatal ward & NICU. Exclusion criteria: Out- born babies and those neonates with a prenatal diagnosis of duct dependent circulation by fetal echocardiography. The measurements of SpO2 were performed using a Massimo Single Extraction Technology (SET) handheld pulse oximeter with a neonatal reusable Nellcor SpO2 sensor OXI-A/N probe. For each newborn, SpO2 was measured by a trained social worker on all the four limbs of the newborn within the first 4 hours of life. The probe was held manually to the wrist or palm and to the sole of the foot, following a random order. It usually required 5-6 minutes for all 4 measurements to be performed.
Dr Johnson coordinated meetings with nursing staff to initiate pulseoximetryscreening program adhering to American Academy of Pediatrics guidelines, collected data from pulseoximetryscreening tests, analyzed the results, and wrote preliminary methods and results section; Dr Lieberman participated in organizational meetings to construct a pulse oximeter screening program, collected data from pulseoximetryscreening tests, and supervised the statistical analysis of the pulseoximetry data; Dr O ’ Leary collected data from pulseoximetryscreening tests, assisted with the data analysis, and wrote the ﬁ rst version of the introduction; Dr Geggel proposed the current investigation to determine the contribution of pulseoximetry in the detection of criticalcongenitalheartdisease in a tertiary-care level-1 nursery, participated in meetings with the nursery staff to construct a pulseoximetry protocol, reviewed the echocardiography reports performed on infants at Brigham and Women ’ s Hospital in the NICU and cardiac ICU at Boston Children ’ s Hospital for infants born at Brigham and Women ’ s Hospital, and patients referred from outside medical centers to Boston Children ’ s Hospital for management of criticalcongenitalheartdisease during the study period, and wrote the full ﬁ rst draft of the manuscript; and all authors approved the ﬁ nal manuscript.
The AAP can play an important role in assuring the safe and effective implementation of screening for CCHD. This includes preparing members to implement screening; engaging pediatricians to participate in quality- improvement activities to ensure that newborn infants are appropriately screened with follow-up echocardio- grams and specialty care, as required; partnering with public health agencies for surveillance of CCHD; and advo- cating for appropriate payment for all screening-related activities. In ad- dition to promoting the implementa- tion of pulseoximetry based screening
The study was conducted in the nursery unit of St Paul ’ s Hospital Millennium Medical College in Addis Ababa, Ethiopia, located at 2,600 m above sea level. Every month 600 newborns are delivered in the hospital. Data were collected prospectively from January 2018 to July 2018. As shown in Figure 1, 941 apparently healthy term neonates were included in the study. Consecutive cases who were asymptomatic at time of discharge from the nursery unit of the hospital were included. SpO2 screening was done for those who ful ﬁ lled the inclusion criteria as de ﬁ ned by: 1) normal vital signs (respiratory rate 30 – 60 breaths/min, pulse rate 100 – 160 beats/min, temperature 36.5 – 37.5°C), 2) no signs of respiratory distress, 3) baby was active and feeding normally, and 4) no murmur or diminished pulses. Newborns who were discharged from the hospital before 6 hours of age and those who had antenatal diagnoses of cardiac disease were excluded from the study. Gestational age was determined based on
Most notably, only statewide surveillance programs would systematically ascertain primary targets that might have been overlooked through current protocols, either by not being screened or by passing a pulseoximetry screen (false negatives). The frequency of missed cases and the related determinants are of critical importance not only in the initial implementation of screening but also as part of continuing quality improvement of the system, and every effort should be taken to minimize missed cases. Such events might occur due to local com- plications with implementation procedures, oximetry thresholds that might be inappropriate in special circum- stances such as high altitudes, or other implementation realities that are inevitable with any widespread point- of-care screening program. The relative impact of these factors might vary in different areas or states; for this reason, surveillance programs ideally would be in place wherever screening occurs. Other data categories detailed in Table 1 of particular interest to surveillance programs include prenatal and clinical diagnoses before newbornscreening; outcomes after screening such as hospitaliza- tions, surgical interventions, or deaths; and cost-effective- ness analyses.
Objective: To evaluate the use of pulseoximetry as a screening tool in early detection of critical CHD specially duct dependent critical CHD in asymptomatic newborn babies. Methodology: A cross sectional study conducted in Dhaka Shishu (Children) Hospital from October 2014 to June 2015. Newborns attended outpatient department or admitted in different wards with having gestational age >35 weeks and age between 24-48 hours were included and pulseoximetryscreening was done. Oxygen saturation measurement <90%, or oxygen saturation measurements <95% in both extremities on three consecutive measurements separated by one hour, or a >3% absolute difference in oxygen saturation between the right hand & foot on three consecutive measurements was considered as pulseoximetryscreening positive. Routine neonatal examination was done and clinical evidence of CHD was noted. Echocardiogram was done to rule out CHD. Data were analyzed by using SPSS and sensitivity, specificity and predictive values were calculated.
The work group chose to focus initially on screening in the well-infant nursery because of the risk of missed cases of CCHD among healthy-appearing newborns. The work group recog- nized the importance of also consid- ering screening within NICUs. How- ever, developing a simple algorithm for the NICU setting is challenging be- cause of the heterogeneity of underly- ing conditions (eg, prematurity, meconium-aspiration syndrome, sep- sis). Unlike the well-infant nursery, many infants in the NICU undergo re- peated medical evaluations, are moni- tored by pulseoximetry, and have lon- ger lengths of stay. However, there was concern that screening only in well-infant nurseries would miss new- borns with short stays in intermediate care nurseries. The work group en- dorsed screening infants in intermedi- ate care nurseries or other units in which discharge is common in the ﬁrst week by using the work-group protocol for screening in the well-infant nurs- ery. The work group chose not to focus on out-of-hospital births, which raise challenging coordination-of-care is- sues, which will be addressed in the future.
Despite the success of our screening program at YNHH, providers should be aware that POxS presents clinical challenges in its implementation. Unlike metabolic newbornscreening performed through a dried blood spot, POxS screening requires a medical professional not only to perform the test, but also to correctly interpret and document the results. 44,45,62 Reporting the results of POxS in a useful format for clinicians is more complex than those of hearing or metabolic screening. It is important that oxygen saturations are recorded and interpreted correctly, as the results have the potential to affect immediate clinical decision making. Though misinterpretation of the algorithm was uncommon, it did occur, reinforcing the need for thorough training of screening staff. Others have proposed quality improvement measures such as an automated alert in the electronic medical record for saturation values outside of the protocol threshold to reduce
On June 2, 2011, Governor Christie of New Jersey signed legislation man- dating newbornpulseoximetryscreening. The law went into effect 90 days later on August 31, 2011, making New Jersey the ﬁ rst state in the nation to implement mandatory screening for CCHD. As such, critical review of the New Jersey experience can provide important lessons for other states implementing or plan- ning to implement statewide CCHD screening. The New Jersey De- partment of Health (NJDOH) led the implementation efforts and estab- lished the New Jersey Critical Con- genital HeartDiseaseScreening Working Group, which includes neo- natologists, cardiologists, nurses, nurse midwives, pediatricians, par- ents, NJDOH staff from the New Jersey Birth Defects Registry, the newbornscreening program, and newborn hearing screening program, as well as representatives from the NJDOH Di- vision of Health Facilities Evaluation and Licensing, the AAP New Jersey Chapter, Maternal and Child Health Consortia, and the New Jersey Hos- pital Association. The NJDOH, with input from members of the CCHD Screening Working Group, developed a recommended screening protocol, trained hospital providers, and in- stituted a 2-pronged approach to data collection. Challenges to imple- mentation identi ﬁ ed in the New Jersey experience were the short implementation period, the unfunded mandate, and barriers associated
In September 2010, criticalcongenital cyanotic heartdisease was approved to be included in a uniform newbornscreening panel on the basis of findings from a comprehensive evidence review by the United States Health and Human Services (HHS) Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC). (12) The objective of this approval was to recognise those newborns with structural heart defects commonly associated with hypoxia in the newborn period who can have significant morbidity, or mortality, with closure of the ductus arteriosus or other physiological changes early in life. (12) Hypoxaemia is a common feature of CHD resulting from mixing of systemic and venous circulations. Central cyanosis occurs when 5g of haemoglobin is deoxy- genated. (13) However, most congenitalheart defects have low levels of hypoxaemia, which would not result in visible cyanosis, and it is with these infants where the need for pulseoximetry to detect potentially life threatening cardiac defects becomes crucial. (11) Many newborns with the targeted congenitalheart defects do not develop clinically significant cyanosis until after nursery discharge. Some lesions (e.g. hypoplastic left heart syndrome) may present with substantial cardiovascular com- promise without obvious cyanosis. Therefore, the working group advised renaming the target conditions “criticalcongenitalheartdisease” (omitting the word “cyanotic”). (12)
A member of the Tennessee state legislature recently proposed a bill that would mandate all newborn infants to undergo pulseoximetryscreening for the purpose of identifying those with critical structural heartdisease before discharge home. The Tennessee Task Force on ScreeningNewborn Infants for CriticalCongenitalHeart Defects was convened on September 29, 2005. This group reviewed the current medical literature on this topic, as well as data obtained from the Tennes- see Department of Health, and debated the merits and potential detriments of a statewide screening program. The estimated incidence of criticalcongenitalheartdisease is 170 in 100 000 live births, and of those, 60 in 100 000 infants have ductal-dependent left-sided obstructive lesions with the potential of presentation by shock or death if the diagnosis is missed. Of the latter group, the diagnosis is missed in ⬃ 9 in 100 000 by fetal ultrasound assessment and discharge examina- tion and might be identified by a screening program. Identification of the missed diagnosis in these infants before discharge could spare many of them death or neurologic sequelae. Four major studies using pulseoximetryscreening were analyzed, and when data were restricted to critical left-sided obstructive lesions, sensitivity values of 0% to 50% and false-positive rates of between 0.01% and 12% were found in asymptomatic populations. Because of this variability and other considerations, a meaningful cost/benefit analysis could not be performed. It was the consensus of the task force to provide a recommendation to the legislature that mandatory screening not be implemented at this time. In addition, we determined that a very large, prospective, perhaps multistate study is needed to define the sensitivity and false-positive rates of lower-limb pulseoximetry screen- ing in the asymptomatic newborn population and that there needs to be continued partnering between the medical community, parents, and local, state, and national governments in decisions regarding mandated medical care.
Seven years after its addition to the US Recommended Uniform Screening Panel, newbornscreening for criticalcongenitalheartdisease (CCHD) using pulseoximetry became mandatory in the United States. Although CCHD newbornscreening reduces morbidity and mortality, there remain important opportunities to improve. An expert panel convened for a 1-day meeting in September 2018, including subject matter experts and representatives from stakeholder organizations. Presentations on CCHD outcomes, variations in approach to screening, and data and quality improvement helped identify improvement opportunities. The expert panel concluded that suf ﬁ cient evidence exists to recommend modifying the current American Academy of Pediatrics algorithm by (1) requiring an oxygen saturation of at least 95% in both (formerly either) the upper and lower extremities to pass and (2) requiring only 1 repeat screen instead of 2 for cases that neither pass nor fail initially. The panel underscored the importance of improving public health reporting by further specifying the targets of screening and criteria for reporting outcomes (false-negative and false-positive cases). The panel also highlighted the need to ensure sufﬁcient public health funding for CCHD newbornscreening and opportunities for education and global
Through a collaborative quality improvement project between the cardiology department at Children’s Healthcare of Atlanta (CHOA) and the neonatology department at Northside Hospital, a retrospective review was conducted on newborn CCHD screening results collected on term infants born between January 1, 2013, and December 31, 2016, at Northside Hospital, a large tertiary birth hospital with 2 delivery campuses in metropolitan Atlanta, Georgia. Full- time pediatric cardiology coverage is provided daily at Northside Hospital by physicians from CHOA. Approximately 80% of infants with CCHD were diagnosed prenatally. Infants with a prenatal diagnosis of CCHD and infants transferred to the NICU before screening were excluded from CCHD pulseoximetryscreening. The study was submitted and approved by the Northside Hospital Institutional Review Board. Aggregate de-identified data were used for analysis. Informed consent was not required because of the retrospective observational nature of the study.
Methods: A full economic assessment of the cost-effectiveness type was conducted from the perspective of society. A decision tree was constructed to establish a comparison between newborn physical examination plus pulse oxi- metry, versus physical examination alone, in the diagnosis of CCHDs. The sensitivity and specificity of pulseoximetry were estimated from a systematic review of the literature; to assess resource use, micro-costing analyses and surveys were conducted. The time horizon of the economic evaluation was the first week after birth and until the first year of life. The incremental cost-effectiveness ratio (ICER) was determined and, to control for uncertainty, deterministic and probabilistic sensitivity analysis were made, including the adoption of different scenarios of budgetary impact. All costs are expressed in US dollars from 2017, using the average exchange rate for 2017 [$2,951.15 COP for 1 dollar]. Results: The costs of pulseoximetryscreening plus physical examination were $102; $7 higher than physical exami- nation alone. The effectiveness of pulseoximetry plus the physical examination was 0.93; that is, 0.07 more than the physical examination on its own. The ICER was $100 for pulseoximetryscreening; that is, if one wishes to increase 1% the probability of a correct CCHD diagnosis, this amount would have to be invested. A willingness to pay of $26.292 USD (direct medical cost) per probability of a correct CCHD diagnosis was assumed.
Congenitalheart defects are the most common group of congenital malformations with a prevalence of 5-10 in every 1000 live births. 8 Early detection of major congenitalheart defects (i.e. those leading to death or requiring invasive intervention before 1 year of age) might improve the outcome of newborn babies. 9 Improvement with early detection is particularly true for critical, duct-dependent lesions in which closure of the ductus arteriosus can result in acute cardio vascular collapse, acidosis and death. 10-12 Screening for congenitalheart defects relies on mid trimester ultrasound scan in which the fetal heart is imaged, and postnatal physical examination that includes assessment of pulses and heart sounds and inspection for cyanosis. Both screening methods have a fairly low detection rate and substantial number of babies are discharged from hospital before congenitalheartdisease are diagnosed. 13-17 Some of these
LOINC # LOINC Name Optionality
73700-7 CCHD NewbornScreening Interpretation R 57716-3 Blood Spot Fiber Paper Card ID R 73699-1 Number of Prior CCHD Screens R 62324-9 Post Discharge provider name R 62328-0 Post Discharge provider telephone number R 62328-0 Post Discharge provider telephone (FAX) number R 73698-3 Reason CCHD Oxygen Saturation Screening Not Performed C 73696-7 Difference Between Preductal and Postductal Oxygen Saturation C 59407-7 Oxygen Saturation in Blood Preductal by PulseOximetry C 73698-3 Reason CCHD Oxygen Saturation Screening Not Performed C 73696-7 Difference Between Preductal and Postductal Oxygen Saturation C 59407-7 Oxygen Saturation in Blood Preductal by PulseOximetry C 73798-1 Perfusion Index Blood Preductal PulseOximetry C 57714-8 Estimated Gestational Age RE
On the basis of new data from the large population based screening activities in Sweden and England, the work group developed a recommendation for screening that was based on what was shown to be effective in those studies. A screen result would be considered positive if -1) Any oxygen saturation measure is <90%, 2) oxygen saturation is <95% in both extremities on three measures, each separated by 1 hour, or 3) There is a >3% absolute difference in oxygen saturation between the right hand and foot on 3 measures, each separated by 1 hour. Any screening that is ≥95% in either extremity with ≤3% absolute difference in oxygen saturation between upper and lower extremity would be considered a “pass” result and screening would end. 25 Figure -1. Additionally,
With the average pulseoximetry value being 97.2% during the first days of life for all newborns, pulseoximetry is an excellent tool to evaluate subclinical hypoxemia, that occurs during transitioning physiology of certain CHD, such as transposition of the great arteries, truncus arteriosus communis, hypoplastic left heart syndrome, total anomalous pulmonary venous connection, tricuspid atresia, tetralogy of Fallot, and pulmonary atresia. These lesions are usually associated with hypoxemia in the newborn period and can cause significant morbidity and mortality if the diagnosis is delayed. In September 2010, the Secretary’s Advisory Com- mittee on Heritable Disorders in Newborns and Children (SACHDNC) considered these seven lesions as primary targets for pulseoximetryscreening in the newborn period on the basis of advice from a technical expert panel. 2 In
The increase in parental declination of screening at the protocol shift could have been a result of the mechanism of consent, because nursing staff were required to consent patients to a more complex algorithm using a longer consent form. This ﬁnding suggests that the informed consent process itself is important to compliance and also suggests that consent forms should be crafted to minimize attention to standard-of-care aspects of the process and instead focus clearly on additional activities for which consent is required (ie, use of data or permission to contact the family in the future).