Research

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 doi: https://doi.org/10.1136/bmj.a3037 (Published 09 January 2009) Cite this as: BMJ 2009;338:a3037
  1. Anne de-Wahl Granelli, cardiac sonographer111,
  2. Margareta Wennergren, consultant obstetrician2,
  3. Kenneth Sandberg, consultant neonatologist3,
  4. Mats Mellander, consultant paediatric cardiologist1,
  5. Carina Bejlum, consultant obstetrician4,
  6. Leif Inganäs, consultant paediatrician5,
  7. Monica Eriksson, consultant obstetrician6,
  8. Niklas Segerdahl, consultant paediatrician7,
  9. Annelie Ågren, research midwife8,
  10. Britt-Marie Ekman-Joelsson, consultant paediatrician9,
  11. Jan Sunnegårdh, consultant paediatric cardiologist1,
  12. Mario Verdicchio, consultant forensic pathologist10,
  13. Ingegerd Östman-Smith, professor of paediatric cardiology111
  1. 1Department of Paediatric Cardiology, Queen Silvia Children’s Hospital, S-416 85 Göteborg, Sweden
  2. 2Department of Obstetrics, Sahlgrenska University Hospital, S-416 85 Göteborg
  3. 3Department of Neonatology, Queen Silvia Children’s Hospital
  4. 4Department of Obstetrics, NÄL Hospital, S-461 85 Trollhättan, Sweden
  5. 5Children’s Department, NÄL Hospital
  6. 6Obstetric Department, Södra Älvsborgs Hospital, S-501 15 Borås, Sweden
  7. 7Children’s Department, Södra Älvsborgs Hospital
  8. 8Department of Neonatology, Hospital of Skövde, S-541 85 Skövde, Sweden
  9. 9Children’s Department, Hospital of Skövde
  10. 10Institute of Forensic Medicine, S-405 30 Göteborg
  11. 11Institute of Clinical Sciences, Sahlgren Academy, Gothenburg University, S-405 30 Göteborg
  1. Correspondence to: I Östman-Smith ingegerd.ostman-smith{at}pediat.gu.se
  • Accepted 5 October 2008

Abstract

Objective To evaluate the use of pulse oximetry to screen for early detection of life threatening congenital heart disease.

Design Prospective screening study with a new generation pulse oximeter before discharge from well baby nurseries in West Götaland. Cohort study comparing the detection rate of duct dependent circulation in West Götaland with that in other regions not using pulse oximetry screening. Deaths at home with undetected duct dependent circulation were included.

Setting All 5 maternity units in West Götaland and the supraregional referral centre for neonatal cardiac surgery.

Participants 39 821 screened babies born between 1 July 2004 and 31 March 2007. Total duct dependent circulation cohorts: West Götaland n=60, other referring regions n=100.

Main outcome measures Sensitivity, specificity, positive and negative predictive values, and likelihood ratio for pulse oximetry screening and for neonatal physical examination alone.

Results In West Götaland 29 babies in well baby nurseries had duct dependent circulation undetected before neonatal discharge examination. In 13 cases, pulse oximetry showed oxygen saturations ≤90%, and (in accordance with protocol) clinical staff were immediately told of the results. Of the remaining 16 cases, physical examination alone detected 10 (63%). Combining physical examination with pulse oximetry screening had a sensitivity of 24/29 (82.8% (95% CI 64.2% to 95.2%)) and detected 100% of the babies with duct dependent lung circulation. Five cases were missed (all with aortic arch obstruction). False positive rate with pulse oximetry was substantially lower than that with physical examination alone (69/39 821 (0.17%) v 729/38 413 (1.90%), P<0.0001), and 31/69 of the “false positive” cases with pulse oximetry had other pathology. Thus, referral of all cases with positive oximetry results for echocardiography resulted in only 2.3 echocardiograms with normal cardiac findings for every true positive case of duct dependent circulation. In the cohort study, the risk of leaving hospital with undiagnosed duct dependent circulation was 28/100 (28%) in other referring regions versus 5/60 (8%) in West Götaland (P=0.0025, relative risk 3.36 (95% CI 1.37 to 8.24)). In the other referring regions 11/25 (44%) of babies with transposition of the great arteries left hospital undiagnosed versus 0/18 in West Götaland (P=0.0010), and severe acidosis at diagnosis was more common (33/100 (33%) v 7/60 (12%), P=0.0025, relative risk 2.8 (1.3 to 6.0)). Excluding premature babies and Norwood surgery, babies discharged without diagnosis had higher mortality than those diagnosed in hospital (4/27 (18%) v 1/110 (0.9%), P=0.0054). No baby died from undiagnosed duct dependent circulation in West Götaland versus five babies from the other referring regions.

Conclusion Introducing pulse oximetry screening before discharge improved total detection rate of duct dependent circulation to 92%. Such screening seems cost neutral in the short term, but the probable prevention of neurological morbidity and reduced need for preoperative neonatal intensive care suggest that such screening will be cost effective long term.

Footnotes

  • We thank everyone, especially nursery and midwifery staff, who contributed to this multicentre study; Peter Skoog, of the department of biomedical engineering, for invaluable help with the pulse oximeters; and Kajsa Boll, Britt-Marie Carlsson, Anna-Maria Edwardsson, Anna Larsson, Josefin Mellander, and Niklas Smith for help with data entry.

  • Contributors: AWG supervised and coordinated the study, set and locked the pulse oximeters, informed and educated all staff involved, handled and analysed the data, participated in the statistical analyses, and drafted and helped revise the manuscript. MW participated in planning the study design, organising the pulse oximetry screening at Östra and Mölndal units, and retrieving their birth numbers. KS participated in planning the study design and retrieving data at Östra and Mölndal and was their neonatal contact person. MM was responsible for organising echocardiography at Queen Silvia Children’s Hospital, jointly collected the reference population in the historical comparison cohort, and helped in manuscript revision. CB was responsible for organising the pulse oximetry screening at NÄL Hospital, and was their obstetric contact-person. LI was responsible for organising echocardiography at NÄL and was their paediatric contact person. ME was responsible for organising the pulse oximetry screening at Borås, retrieving birth numbers, and was their obstetric contact person. NS was responsibility for organising echocardiography at Borås and was their paediatric contact person. AÅ was responsible for organising the pulse oximetry screening at Skövde, retrieving birth numbers, and was their neonatal contact person, BMEJ was responsible for organising echocardiography at Skövde, and was their paediatric contact person. JS provided the logbook over those not being referred for or denied surgery and jointly collected the reference population in the historical comparison cohort. MV retrieved and analysed infant data from the forensic database. IÖS conceived and was extensively involved in the design of the study, interpretation of the results, statistical analyses, and writing and revising the manuscript. All authors reviewed and approved the final manuscript. IÖS is guarantor for the study.

  • Ewa-Lena Bratt conducted the pilot period at Östra together with AWG.

  • Funding: Grants from the Regional Science and Education Foundation, West Götaland Region, supporting inter-regional collaboration, and a LUA-ALF project grant from Gothenburg University.

  • Competing interests: None declared.

  • Ethical approval: The Gothenburg University Research and Ethics Committee approved this study (application No Ö670-03).

  • Provenance and peer review: Not commissioned.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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