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Dr Bhanu K Bhakhri

"The Journal of Clinical and Diagnostic Research (JCDR) has been in operation since almost a decade. It has contributed a huge number of peer reviewed articles, across a spectrum of medical disciplines, to the medical literature.
Its wide based indexing and open access publications attracts many authors as well as readers
For authors, the manuscripts can be uploaded online through an easily navigable portal, on other hand, reviewers appreciate the systematic handling of all manuscripts. The way JCDR has emerged as an effective medium for publishing wide array of observations in Indian context, I wish the editorial team success in their endeavour"

Dr Bhanu K Bhakhri
Faculty, Pediatric Medicine
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute, Noida
On Sep 2018

Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"

Dr Mohan Z Mani,
Professor & Head,
Department of Dematolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018

Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."

Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018

Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."

Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018

Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."

Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
On Sep 2018

Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."

Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata

Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
On Aug 2018

Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".

Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
On Aug 2018

Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".

Dr. Mamta Gupta
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018

Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.

Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."

Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011

Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."

Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011

Important Notice

Original article / research
Year : 2022 | Month : May | Volume : 16 | Issue : 5 | Page : SC11 - SC14 Full Version

Neonatal Pulse Oxymetry Screening for Detection of Congenital Heart Disease in Asymptomatic Newborns: A Cross-sectional Study from a Tertiary Care Hospital

Published: May 1, 2022 | DOI: https://doi.org/10.7860/JCDR/2022/55706.16364

Raghava Polanki, Kalyan Kumar Bolishetti, Kavitha Shanigaram, Sreelekha Palle, Syed Babjan, Lalitha Devi Sreeramdasu

1. Assistant Professor, Department of Paediatrics, Niloufer Hospital, Osmania Medical College, Hyderabad, Telangana, India. 2. Assistant Professor, Department of Paediatrics, Niloufer Hospital, Osmania Medical College, Hyderabad, Telangana, India. 3. Assistant Professor, Department of Paediatrics, Niloufer Hospital, Osmania Medical College, Hyderabad, Telangana, India. 4. Assistant Professor, Department of Paediatrics, Niloufer Hospital, Osmania Medical College, Hyderabad, Telangana, India. 5. Senior Resident, Department of Paediatrics, Sri Venkateswara Medical College, Tirupathi, Andhra Pradesh, India. 6. Senior Resident, Department of Paediatrics, Sri Venkateswara Medical College, Tirupathi, Andhra Pradesh, India.

Correspondence Address :
Dr. Sreelekha Palle,
House No: 11-5-95/12NP, Jaiswal Colony, Road No. 5, Venkatewara Colony,
Saroor Nagar, L B Nagar, Hyderabad-500035, Telangana, India.
E-mail: drsrilekha05@gmail.com


Introduction: Screening for Congenital Heart Diseases (CHD) depends on the antenatal ultrasonography and clinical examination of the newborn, however both these methods have low detection rates and often life-threatening congenital heart diseases are missed. Pulse Oximetry (PO) is an easy, accurate, rapid, non invasive method of detecting hypoxaemia. The purpose of using PO to identify Critical Congenital Heart Disease (CCHD) is that clinically non detectable minimal hypoxaemia can be detected by pulseoximetry.

Aim: To study the accuracy of pulse oxymetry as a screening tool for early detection of critical congenital heart diseases in asymptomatic newborns.

Materials and Methods: This cross-sectional study was conducted in the Department of Paediatrics and the Postnatal Ward of Obstetrics and Gynaecology at Sri Venkateswara Medical College, Tirupathi, Andhra Pradesh, India, from January 2017 to December 2020. All the term asymptomatic newborns of age more than 24 hours were screened using PO. Screening was positive if a: PO was <90% in right hand or foot at any stage of screening, b was 90% to <95% on both; there was >3% absolute difference in oxygen saturation between the right hand and foot on three consecutive measures (each separated by one hour). All the screen positive babies were subjected to 2D echocardiography. All statistical analyses were performed using OpenEpi website epicalculator, and Chi-square’s test was used to calculate the p-value.

Results: The mean gestational age (weeks) was 38±4 days. Out of 14,400, PO screening was positive in 45 babies, and subsequent echocardiography detected CHD in 30 babies. The sensitivity was 66.67%, positive predictive value was 66.67%, negative predictive value was 99.90%, with a diagnostic accuracy of 99.79%. On 2D electrocardiography, 30 were true positive cases, whereas, false positives and false negatives were 15 each. Remaining 14340 newborns were true negatives.

Conclusion: Pulse oximetry is a safe, accessible, feasible test that can be used for early detection of CCHD’s that are often undetected on antenatal ultrasonography.


Critical congenital heart disease, Echocardiography, Hypoxemia, Oxygen saturation, Term newborn

Congenital Heart Diseases (CHD) are the most common group of birth anomalies, with a prevalence of around 6 to 11 per 1000 live births (1),(2),(3). They account to 10% of all infant deaths, and 46% of deaths related to congenital anomalies (2),(4). Of those children with CHD, 25% have Critical Congenital Heart Disease (CCHD) (1). The CCHD is defined as cardiac lesions that require surgery or cardiac catheterization within the first month (or within the first year by different definitions) of life to prevent death or severe end organ damage (5).

Screening strategies to detect congenital heart defects include antenatal ultrasound and physical examination of the newborn baby. Both techniques have a fairly low detection rate for isolated defects and many babies are discharged from hospital before diagnosis (2),(3).

Most early deaths due to undiagnosed cardiac malformations occur in babies with obstructions of the left ventricular outflow tract, with majority likely to have appreciable right to left ductal flow at some stage (6). The diagnosis in these babies is missed as they have no clinically detectable physical signs, depicting the need for formulating a different strategy for early detection of CCHDs. Although healthcare systems and governments worldwide are considering pulse oximetry as a screening strategy for newborn babies, uncertainty exists about false-positive rates and test accuracy. In 2011, the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), in collaboration with the American Academy of Pediatrics, the American College of Cardiology Foundation, and the American Heart Association, convened a work group to outline implementation strategies for pulse oximetry screening in newborns for CHD (8). After reviewing data from existing large studies in Sweden and the United Kingdom, the work group proposed a screening protocol based on results of measurements from the right hand (preductal) and either foot (postductal) (6),(7),(8).

Routine clinical examination of newborns lack sensitivity for detecting CHDs (9),(10). Pulse oximetry is an accurate, non invasive test used for quantifying hypoxaemia that has been widely used in many large scale studies as screening tool for detecting CHDs (6),(7),(8),(9),(10),(11). The purpose of the present study was to determine the diagnostic accuracy of pulse oximetry for early detection of CCHD in asymptomatic term newborns.
Material and Methods
This cross-sectional study was conducted in the Department of Paediatrics and the Postnatal Ward of Obstetrics and Gynaecology at Sri Venkateswara Medical College, Tirupathi, Andhra Pradesh, India, from January 2017 to December 2020. The Institutional Ethics Committee approval was obtained (Letter No. 73/2016, dated 11/10/2016). An informed consent was obtained from parents before initial screening.

Sample size calculation: The sample size was calculated based on the prevalence of CHDs (1),(2),(3) and relative precision by using formula (12): 4 pq/l2

where, prevalence 9 per 1000 live births and the maximum allowable error as 10.

Inclusion criteria: All the asymptomatic term newborn babies delivered in the study institution were included in this study.

Exclusion criteria: Newborns with respiratory disorders, babies who were antenatally diagnosed with CHDs, premature babies less than 37 weeks of gestation, those who had cardiac signs on examination, and parents who refused to give consent were excluded from this study.

Study Procedure

Pulse oximetry screening was done using motion-tolerant pulse oximeter (masimo SET radical 7) and probes were cleaned with alcohol swab before each use. Pulse oximetry was conducted on a quiet or sleeping newborn and recorded on right upper extremity and either right or left foot of all the asymptomatic newborns who met the inclusion criteria.

• Negative screen- If pulse oximetry was ≥95% in right hand or either foot with ≤3% absolute difference in oxygen saturation between right hand and foot.
• Positive screen-
a. If pulse oximetry was <90% in right hand or foot at any stage of screening,
b. If pulse oximetry was 90% to <95% on both,
c. If there was >3% absolute difference in oxygen saturation between the right hand and foot on three consecutive measures each separated by one hour.

All the newborns tested positive were subjected to 2D echocardiography to confirm the cardiac disease (Table/Fig 1) (13).

Statistical Analysis

All statistical analyses were performed using OpenEpi website epicalculator, and Chi-square’s test was used to find p-value. Collected data was analysed for specificity, sensitivity, 95% confidence interval, diagnostic accuracy, prevalence of CHD’s, positive and negative predictive values. Statistical significance was defined as p-value <0.05.
Out of 28,800 live newborns delivered in the Maternity Ward, 9840 preterm newborns were excluded and out of 18,960 term newborns, 4560 term newborns were excluded due to early discharge, who had respiratory distress, antenatally diagnosed CHDs, parents not giving consent, insufficient data and who underwent pulseoximetry but refused for 2D echocardiography. A total of 14,400 asymptomatic term newborns who met the inclusion criteria were screened by pulse oximetry. Mean gestational age (weeks) was 38±4 days, and male to female ratio was 1.2:1 (Table/Fig 2). Among 14,400 newborns screened, 30 newborns were true positive (both 2D echocardiograpy and pulse oximetry positive), 15 were false positive (2D echocardiograpy negative and pulse oximetry positive), 15 were false negative (2D echocardiography positive and pulse oximetry negative) and remaining 14340 were true negatives (p-value <0.001). Pulse oximetry positive rate was 0.31%, with a true positive rate of 0.20%, false positive rate of 0.10%, and false negative rate of 0.10%. All the 15 false negative babies were detected to have small Ventricular Septal Defect (VSD), on echocardiography (Table/Fig 3).

Among 14,400 asymptomatic newborns screened, 12.7% newborns had family history of consanguinity. About 15 out of 45 newborns with CHD had family history of consanguinity accounting for 33.33%.

Specificity of pulse oximetry screening was 99.90%, sensitivity was 66.67%, positive predictive value was 66.67%, negative predictive value was 99.90% with a diagnostic accuracy of 99.79%. Prevalence of CHD in asymptomatic term new borns was 0.3% (Table/Fig 4), (Table/Fig 5).
Congenital heart defects are the foremost common group of congenital malformations. Early detection of major congenital heart defects (i.e., those resulting in death or requiring invasive intervention before 1 year of age) might improve the end result of newborn babies. Improvement with early detection is especially true for critical, duct-dependent lesions during which closure of the ductus arteriosus can result in acute cardiovascular collapse, acidosis, and death (14).

Among 14,400 newborns screened 1830 babies (12.7%) had history of consanguinity, 15 out of 45 newborns with CHD’s had history of consanguinity (33.33%). The sensitivity of pulse oximetry in screening CHD in asymptomatic term newborns was 66.67%, positive predictive value was 66.67%, with adiagnostic accuracy of 99.79%. All the 15 false negative babies were found to have small ventricular septal defect. In the present study, the pulse oxymetry screening had low sensitivity, as half of the babies with CHDs were noncritical,and also low false positivity was seen as measurements were recorded in term babies after 24 hours of life.

Koppel RI et al., performed pulse oximetry screening for identifying critical CHD by one-time measurement of postductal saturation (saturation <95% at >24 hours) on all asymptomatic newborns (n=11,281) in the well-infant nurseries of two participating hospitals in New Hyde Park, New York. This study concluded 60% sensitivity; 99.95% specificity; 75% positive predictive value, 99.98% negative predictive value, and accuracy of 99.97%. These results were comparable with the present study (14).

Mahle WT et al., conducted a systematic review of the literature about current screening methods for CCHD, burden of missed and/or delayed diagnosis of CCHD, rationale of oximetry screening, and clinical studies of oximetry inotherwise asymptomatic newborn. The analysis of pooled studies performed after 24 hours of life showed the estimated sensitivity was 69.6%, and the positive predictive value was 47.0%; however, sensitivity varied widely from 0% to 100%. False-positive screens were seen in 0.035% (5).

Saxena A et al., did cross-sectional observational study on a cohort of 19,009 babies. Sensitivity of pulse oximetry for identification of CHD was 47.2% (95% CI 39.6% to 54.9%). The sensitivity of clinical assessment for identification of CHD was 25.2% (95% CI 19.1% to 32.4%). The combination of pulse oximetry andclinical assessment enhanced the sensitivity to 65.4% (95% CI 57.7% to 72.4%) and this was statistically more significant when compared to pulse oximetry screening alone (p-value <0.01) or performingclinical assessment alone (p-value <0.01). The specificities for oximetry, clinical assessment and for both combined were 68.3% (95% CI 67.7% to 69%), 97.3% (95% CI 97.1% to 97.6%) , 66.7% (95% CI 66% to 67.4%) respectively. Sensitivity of this study ishigher than the present study, as the combination of physical examination and pulse oximetry screening had added benefits (11).

Ruangritnamchaiet C et al., conducted pulse oximetry on 1,847 clinically normal newborns at 24-48 hours of age at Synphaet Hospital, Bangkok and a SpO2 value below 95% was considered positive.In this study,the sensitivity was 100%, the specificity was 99.8%, positive predictive value was 100%, negative predictive value was 100% with a diagnostic accuracy of 99.8% in detecting CCHD. Both sensitivity and positive predictive values of the study is higher than the present study, because only CCHD were considered during analysis (but the specificity and negative predictive values are comparable) (15).

Zhao QM et al., conducted a large scale, prospective, multicentered study in the newbornsof age 6-72 hrs at 18 hospitals in China during the period August 2011 and November 2012. Total 1,22,738 consecutive newborn babies were screened (1,20,707 asymptomatic and 2,031 symptomatic) with 157 critical and 330 major CHD were detected (16). In the asymptomatic newborns, the sensitivity of pulseoximetry plus physical examination was 93.2% for critical congenital heart disease and 90.2% for major disease. The combination of pulse oximetry and clinical assessment enhanced thesensitivity from 77.4% to 93.2%. The false positive percentage for identification of CCHD was 2.7% (3298 of 120,392) for clinical assessment alone and 0.3% (394 of 120,561) for pulse oximetry screening alone. False positive percentage was 0.1%. Sensitivity of pulse oxymetry screening in this study is more than the present study, but false positive rates of present study is comparable (16).

Taksande AM et al., (17), studied accuracy of pulse oximetry screening for detecting critical congenital heart disease in the newborns at arural hospital of Central India. In this study pulse oximetry screening was performed on 2110 newborns within 4 hours of life. When SpO2 value of less than 90% was considered positive the pulse oximetry screening had 100% sensitivity, 99.95% specificity, 87.50% positive predictive value, 100% negative predictive value, and when SpO2 value below 95% was considered positive, the pulse oximetry screening had 100% sensitivity, 95.08% specificity, 6.36% positive predictive value, 100% negative predictive value. The present study had specificity which is comparable to the findings of Taksande AM et al., (17). The positive predictive value of the present study is high when compared to this study, as the screening was done after 24 hrs in the present study, positive predictive value is higher than the present study when Spo2 cut-off was taken as less than 90%.

Turska Kmiec´ A et al., did screening for critical congenital heart defects in 51,908 asymptomaticnewborns. The CCHD was diagnosed solely by pulse oximetry in 15 newborns, which constituted 18.3% of all CCHD; 14 (0.026%) were false positives and four were false negative. The sensitivity of the test was 78.9% and specificity 99.9%. The positive predictive value was 51.7% and negative 99.9% (18). The sensitivity was higher than the present study due to large sample size and specificity was similar.

Prevalence of CHD in asymptomatic newborns was found to be three in 1000 newborns (0.3% disease prevalence) with 0.34% and 0.23% prevalence seen male and female babies respectively. Male babies had a higher risk of CHD than female babies. SGA babies had high probability of congenital heart disease when compared to AGA babies. The prevalence of CHD in the present study is lower when compared to those by Saxena A et al.,(0.83%), Zhao QM et al., (0.87%),Taksande AM et al.,(2.18%), Ruangritnamchai C et al., (0.58%) (11),(15),(16),(17). The reason may be the inclusion of only asymptomatic (both term and preterm) newborns in all these studies.

In the present study, CHDs were detected in 30 babies who were screen positive. Mild pulmonary stenosis with ventricular septal defect was seen in 15 babies, and Transposition of Great Arteries (TGA) was seen in 15 babies.


The study was conducted in only one centre and it necessitates the need for multicentre screening.
Pulse oximetry is a rapid, non invasive, easily accessible and acceptable screening tool for detecting CHDs in asymptomatic newborns.The results of the present study strongly indicate that pulse oximetry screening is an accurate, sensitive and specific tool for detecting CHDs in clinically normal newborns. The increasing availability of treatment modalities for newborns with major CHDs warrant early detection crucial to reduce mortality and long-term morbidities. Hence, authors recommend pulse oximetry screening should be included in the routine newborn examination at all nurseries.
Jullien S. Newborn pulse oximetry screening for critical congenital heart defects. BMC pediatrics. 2021;21(1):01-09. Doi: 10.1186/s12887-021-02520-7.   [CrossRef]  [PubMed]
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Luna MS, Muñuzuri AP, López ES, Castellanos JL, Fernández IB, Campillo CW, et al. Pulse oximetry screening of critical congenital heart defects in the neonatal period. The Spanish National Neonatal Society recommendation. Anales de Pediatría (English Edition). 2018;88(2):112-e1.   [CrossRef]
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Mahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, et al. Role of pulse oximetry in examining new-borns for congenital heart disease: A scientific statement from AHA and AAP. Pediatrics. 2009;124(2):823-36.   [CrossRef]  [PubMed]
Ewer AK, Middleton LJ, Furmston AT, Bhoyar A, Daniels JP, Thangaratinam S, et al. Pulse oximetry screening for congenital heart defects in newborn infants (PulseOx): A test accuracy study. Lancet. 2011;378(9793):785-94. Doi: 10.1016/S0140-6736(11)60753-8. Epub 2011 Aug 4. PMID: 21820732.   [CrossRef]
de-Wahl Granelli A, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganäs L, et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338:a3037. Doi: 10.1136/bmj.a3037. PMID: 19131383; PMCID: PMC2627280.   [CrossRef]  [PubMed]
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Saxena A, Mehta A, Ramakrishnan S, Sharma M, Salhan S, Kalaivani M, Juneja R. Pulse oximetry as a screening tool for detecting major congenital heart defects in Indian newborns. Arch Dis Child Fetal Neonatal Ed. 2015;100(5):F416-21.   [CrossRef]  [PubMed]
Mohapatra SC, Mishra B. Sampling in research series 2: Basic concepts in estimating sample size. Journal of Advanced Research in Medical Science & Technology. 2020;07(02):19-21.   [CrossRef]
Martin GR, Ewer AK, Gaviglio A, Hom LA, Saarinen A, Sontag M, et al. Updated Strategies for Pulse Oximetry Screening for Critical Congenital Heart Disease. Pediatrics. 2020;146(1):e20191650.   [CrossRef]  [PubMed]
Koppel RI, Druschel CM, Carter T, Goldberg BE, Mehta PN, Talwar R, et al. Effectiveness of pulse oximetry screening for congenital heart disease in asymptomatic newborns. Pediatrics. 2003;111(3):451-55.   [CrossRef]  [PubMed]
Ruangritnamchai C, Bunjapamai W, Pongpanich B. Pulse oximetry screening for clinically unrecognized critical congenital heart disease in the newborns. Images Paediatr Cardiol. 2007;9(1):10-15. PMID: 22368668; PMCID: PMC3232575.
Zhao QM, Ma XJ, Ge XL, Liu F, Yan WL, Wu L, et al. 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;384(9945):747-54. Doi: 10.1016/S0140-6736(14)60198-7. Epub 2014 Apr 22.   [CrossRef]
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DOI and Others
DOI: 10.7860/JCDR/2022/55706.16364

Date of Submission: Feb 15, 2022
Date of Peer Review: Mar 12, 2022
Date of Acceptance: Apr 29, 2022
Date of Publishing: May 01, 2022

• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. No

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