Nordic pulse oximetry screening - implementation status and proposal for uniform guidelines

Peer reviewe

Effectiveness of neonatal pulse oximetry screening for detection of critical congenital heart disease in daily clinical routine—results from a prospective multicenter study

Pulse oximetry screening (POS) has been proposed as an effective, noninvasive, inexpensive tool allowing earlier diagnosis of critical congenital heart disease (cCHD). Our aim was to test the hypothesis that POS can reduce the diagnostic gap in cCHD in daily clinical routine in the setting of tertiary, secondary and primary care centres. We conducted a prospective multicenter trial in Saxony, Germany. POS was performed in healthy term and post-term newborns at the age of 24–72 h. If an oxygen saturation (SpO2) of ≤95% was measured on lower extremities and confirmed after 1 h, complete clinical examination and echocardiography were performed. POS was defined as false-negative when a diagnosis of cCHD was made after POS in the participating hospitals/at our centre. From July 2006–June 2008, 42,240 newborns from 34 institutions have been included. Seventy-two children were excluded due to prenatal diagnosis (n = 54) or clinical signs of cCHD (n = 18) before POS. Seven hundred ninety-five newborns did not receive POS, mainly due to early discharge after birth (n = 727; 91%). In 41,445 newborns, POS was performed. POS was true positive in 14, false positive in 40, true negative in 41,384 and false negative in four children (three had been excluded for violation of study protocol). Sensitivity, specificity, positive and negative predictive value were 77.78%, 99.90%, 25.93% and 99.99%, respectively. With POS as an adjunct to prenatal diagnosis, physical examination and clinical observation, the percentage of newborns with late diagnosis of cCHD was 4.4%. POS can substantially reduce the postnatal diagnostic gap in cCHD, and false-positive results leading to unnecessary examinations of healthy newborns are rare. POS should be implemented in routine postnatal care

Pulse oximetry: Evaluation of a potential tool for early detection of critical congenital heart disease

Background: About one third of newborns with life-threatening congenital heart disease leave newborn nurseries without the problem being recognized, and risk death or serious damage from circulatory collapse. The main aim of this thesis has been to evaluate if routine newborn screening with pulse oximetry could improve early in-hospital detection of newborns with duct-dependent circulation (DDC). Papers I, II and IV are methodological studies describing optimal screening cut-offs for pulse oximetry (Paper I), normal range for perfusion index; PPI (Paper II), and deviation of pulse oximetry values from true arterial saturation in cyanosed children (Paper IV). Paper III includes a multicentre screening-study that tests the method prospectively in all newborn nurseries in West Götaland Region (WGR) on 39821 newborns, with blind comparison with neonatal physical examination (NPE), as well as a complete cohort comparison of all newborns with DDC in WGR with all other referring regions (ORR) not screening newborns, and a cost-benefit analysis of screening. Results: Best sensitivity for DDC was achieved with both pre- and postductal saturation cut-off +3% with a New-generation oximeter(NGoxi) on 3 repeated measurements. 29 babies with DDC remained undetected until the discharge examination. NGoxi-screening detected 18/29 (62%) but combining with NPE increased sensitivity to 24/29 (83%). A positive pulse oximetry screening gives a relative risk of 719.8 (95% confidence interval 350.3 to 1479; p 7% of the arterial blood gas saturation occurred in 66.7% (10/15) of CToxi-readings and in 40.0% (6/16) of NGoxi-readings in the below 80% saturation range. Conclusion: Adding NGoxi-screening to neonatal physical examination significantly improved detection of DDC, detected 100% of duct-dependent pulmonary circulation (present in 2 of 5 undiagnosed deaths in ORR), yielded only 0.17% false-positives, and came out cost-neutral