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

Feasibility of implementing pulse oximetry screening for congenital heart disease in a community hospital

OBJECTIVE: Pulse oximetry has been recognized as a promising screening tool for critical congenital heart disease (CCHD). The aim of this research was to study the feasibility of implementation in a community hospital setting. STUDY DESIGN: Meetings were conducted to determine an implementation plan. Pulse oximetry was performed on the right hand and foot after 24 h of age. Newborns with a saturation ⩽95% or a ⩾3% difference were considered to have a positive screen. Screening barriers, screening time and ability to effectively screen all eligible newborns were noted. RESULT: From January 2009 through May 2010, of 6841 eligible newborns, 6745 newborns (98.6%) were screened. Of the nine infants with positive pulse oximetry screens, one had CCHD, four had CHD and four others were determined to have false positive screens. Average screening time was 3.5 min (0 to 35 min). CONCLUSION: Pulse oximetry can be implemented successfully in community hospitals without an excessive number of false positives or additional nursing staff